Obese PatientsNCT07084753
Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy
A study testing Levobupivacaine, Dexamethasone contained in the solution for thoracic paravertebral block and Adrenaline in people with Obese Patients and Bariatric Surgical Pain, run by IVO JURISIC at 1 site in Croatia.
Trial summary
Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obese Patients, Bariatric Surgical Pain, Bariatric Surgery (Sleeve Gastrectomy )
- What is being tested?
- Levobupivacaine, Dexamethasone contained in the solution for thoracic paravertebral block and Adrenaline
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCroatia
- Study dates
- 30 Jul 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)
- body mass index of 30 kg/m² or greater
- patients classified as ASA status 2-3.
Who cannot join
- allergies to the intended medications
- patient refusal
- uncontrolled psychiatric disorders
- intracranial pathology
- cerebrovascular damage
- any factors impairing effective communication
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- Additional Exclusion Criteria:
- For patients receiving thoracic paravertebral block (TPVB):
- the presence of infection at the puncture site
- For the OFA group:
- 2nd or 3rd-degree atrioventricular block
- bradycardia with a heart rate below 50 beats per minute
- coronary artery disease,
- cardiomyopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
University Hospital Dubrava
Zagreb, City of Zagreb, 10000
IVO JURISIC, MD, +385989050015, i.jurisic.kbd@gmail.com
IVO JURISIC, MD
About this study
Official title: Comparison of Opioid-based Anesthesia, Opioid-free Anesthesia Based on Intravenous Drugs and Opioid-free Anesthesia With Thoracic Paravertebral Block, in Patients Undergoing Laparoscopic Gastric Bypass Surgery for Obesity
Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. A thoracic paravertebral block is performed by inserting a needle into the intercostal spaces on the back, approximately 4 cm lateral to the spine. Many studies support excellent pain control with this technique, during and after surgery in thoracic and abdominal surgery. Investigators aim to achieve faster patient mobility after surgery, rapid recovery of bowel function, reduced nausea and vomiting, and maximum pain control. The use of opioids, which can additionally cause respiratory suppression and drowsiness, is avoided.
At any time in case of need to switch from laparoscopic to open surgery, equally adequate anesthesia and postoperative analgesia are ensured without the need to change the approach to the same. In this study, the basic scientific assumption (hypothesis) of the researchers is that non-opioid anesthesia with thoracic paravertebral block provides adequate pain control during and long-term after the surgical procedure, without the side effects of opioid anesthesia.
The main goal of the study is to determine which type of anesthesia results in the best pain control and most significantly reduces complications of anesthesia and surgery in overweight patients who are scheduled for laparoscopic longitudinal gastrectomy and partial/total gastrectomy.
Read the detailed description
Morbid obese patients scheduled for laparoscopic sleeve gastric resection need specific care during surgery and post-surgery. Postoperative pain management of these patients after this type of surgery is a challenge because of the high prevalence of nausea, vomiting, and higher risk of respiratory depression in obese patients, making the use of opioids undesirable. Various techniques have been used during and after surgery to control moderate to severe pain for early mobilization: OFA (opioid-free anesthesia) based on intravenous use of dexmedetomidine, ketamine, and lidocaine, or OBA (opioid-based anesthesia) in combination with regional anesthesia, to reduce the use of opioids. Regional anesthesia can be used as an additional modality of analgesia within OFA (opioid-free anesthesia) or opioid-based anesthesia (OBA), which either completely avoid the use of opioids or significantly reduce them. Investigators will compare opioid-based general anesthesia (OBA group) as the standard of anesthesia for bariatric surgery with intraoperative opioid- free anesthesia based on thoracic paravertebral block (TPVB group) and intraoperative opioid-free anesthesia based on intravenous dexmedetomidine, ketamine, and lidocaine (OFA group). The primary objective is to compare pain levels as measured by the 0-10 NRS and to compare opioid and analgesic consumption in the perioperative period.
- Conditions
- Obese Patients, Bariatric Surgical Pain, Bariatric Surgery (Sleeve Gastrectomy ), Non-Opioid Pain Management, PONV, Postoperative Analgesia
- Being tested
- Levobupivacaine, Dexamethasone contained in the solution for thoracic paravertebral block, Adrenaline, Dexmedetomidin, ketamine
- Keywords
- thoracic paravertebral block, obese patients, bariatric surgery, sleeve gastrectomy, postoperative pain management, anesthesia recovery period, non-opioid anesthesia, recovery after bariatric surgery, TPVB, OFA based on thoracic paravertebral block, Visceral pain, Postoperative, Opioid based anesthesia, Opioid free anesthesia, OBA, OFA, Recovery Period, Anesthesia, Non-Opioid Pain Management, PONV, Postoperative analgesia, Postoperative pain
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative, Visceral Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).
Dexamethasone contained in the solution for thoracic paravertebral blockDrug
Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).
AdrenalineDrug
Used in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline).
DexmedetomidinDrug
A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.
ketamineDrug
A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.
LidocainDrug
A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour.
SufentanilDrug
Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg/kg ideal body weight), and rocuronium (0.8 to 1 mg/kg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room.
Opioid free anesthesia based on thoracic paravertebral blockProcedure or surgery
Also called OFA based on TPVB
Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized without the use of opioids, with general anesthesia and pain blockade using a thoracic paravertebral block
Opioid based AnesthesiaProcedure or surgery
Patients scheduled for laparoscopic sleeve gastrectomy will be anesthetized with opioids and general anesthesia
Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaineProcedure or surgery
Also called OFA
Patients who are scheduled for laparoscopic gastrectomy will be anesthetized without the use of opioids and under general anesthesia, with analgesia by intravenous administration of dexmedetomidine, ketamine and lidocaine.
Ultrasound guided thoracic paravertebral blockDevice
Also called Ultrasound guided TPVB
Patients are positioned prone, with the identification of the 1st rib achieved using a convex XX Hz ultrasound probe. The left and right transverse processes of the 5th, 7th, and 9th thoracic vertebrae are marked accordingly. TPVB is executed in a paramedian sagittal oblique scan utilizing an in-plane needle insertion approach at the Th5, Th7, and Th9 levels bilaterally. An insulated echogenic needle, sized between 10-15 cm and 22-20 G, is employed. The skin and subcutaneous tissue at each level are infiltrated with 1.5 ml of 1% lidocaine.
Ultrasound guidance combined with nerve stimulation (dual monitoring) is utilized at each corresponding paravertebral space. Verification of the paravertebral space is established through visualization of pleural displacement, as observed via the ultrasound probe following the injection of 1 ml of 5% glucose, as well as via a motor response at a current intensity of 0.3-0.5 mA.
Nerve stimulator for peripheral nerve blocksDevice
During the application of the thoracic paravertebral block, verification of the distance of the insulated echogenic needle tip from the thoracic spinal nerve is monitored using via a motor response at a current intensity of 0.3-0.5 mA.
Metoclopramide 10mgDrug
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and metoclopramide (10 mg) intraoperatively
Ondasetron 4mgDrug
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intraoperatively.
ThiethylperazineDrug
To prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and thiethylperazine (6.5 mg) intravenously.
Dexamethasone, 8 mg intravenouslyDrug
To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Opioid based anesthesia (OBA) | Active comparator | Premedication: pantoprazole 40 mg i.v. 1h before surgery. Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg/kg ideal body weight), and rocuronium (0.8 to 1 mg/kg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room. To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). For pain levels of 4 or higher on a numerical rating scale (NRS), treatment options include metamizole (2.5 g), pethidine (25 to 100 mg), or tramadol (100 mg). For nausea and vomiting, intravenous doses of ondansetron or metoclopramide are provided as needed. Receives: Drug: Sufentanil; Procedure: Opioid based Anesthesia; Drug: Metoclopramide 10mg; Drug: Ondasetron 4mg; Drug: Dexamethasone, 8 mg intravenously |
| Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine | Active comparator | Premedication: pregabalin 75 mg peroraly et pantoprazole 40mg i.v. A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. After this initial period, anesthetic induction is conducted using propofol at a dose of 1-2 mg/kg IBW and rocuronium at 0.8-1 mg/kg IBW. Anesthesia is sustained with sevoflurane maintained at 0.5-1 MAC, adjusted per BIS readings. The anesthetic mixture was maintained at a rate of 5-10 ml per hour adjusted according to the patient's blood pressure and pulse. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). To prevent nausea and vomiting, patients receive intraoperative dexamethasone 8 mg and thiethylperazine 6.5 mg intravenously. Receives: Drug: Dexmedetomidin; Drug: ketamine; Drug: Lidocain; Procedure: Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine; Drug: Thiethylperazine; Drug: Dexamethasone, 8 mg intravenously |
| Opioid free anesthesia based on thoracic paravertebral block (TPVB) | Experimental | Premedication: pantoprazol 40mg i.v. Preoperative TPVB is executed at the Th5, Th7, and Th9 levels bilaterally. The skin at each level are infiltrated with 1.5 ml of 1% lidocaine. Subsequently, 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level and flushed with 1 ml of 5% glucose. In the operating room a induction is carried out with propofol administered at a dosage of 2-2.5 mg/kg of ideal body weight (IBW) and rocuronium at 0.8-1 mg/kg of IBW. Anesthesia is maintained with an infusion of propofol at 100 mcg/kg of total body weight (TBW) per minute, with adjustments made to achieve a targeted BIS value between 40-60. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). Prophylaxis of PONV is dexamethasone 8 mg previously administered within the thoracic paravertebral block, with intraoperative administration of 10 mg metoclopramide.
Completely opioid-free interventions. Receives: Drug: Levobupivacaine; Drug: Dexamethasone contained in the solution for thoracic paravertebral block; Drug: Adrenaline; Procedure: Opioid free anesthesia based on thoracic paravertebral block; Device: Ultrasound guided thoracic paravertebral block; Device: Nerve stimulator for peripheral nerve blocks; Drug: Metoclopramide 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
a) Postoperative pain levels measured by the 0-10 Numerical rating scale (NRS). b) Opioid analgesic consumption (Morphine milligram equivalents- MME).
- Self-reported pain levels recorded at multiple time points:30 minutes post- surgery, every three hours for the first 24 hours, and three times daily for the following nine days. Zero indicates no pain, ten is the worst possible pain.
- Use of opioids (sufentanil, pethidine, tramadol) before, during and after surgery. Sufentanil in micrograms, pethidine and tramadol in milligrams. Values are converted into Morphine milligram equivalents (MME),
Measured: 10 days
Secondary outcomes (1)
a) Self-reported incidence of PONV after surgery. b) Time in the postoperative care unit (PACU) after surgery. c) Time to first mobilization after surgery. d) Time to fluid intake after surgery.
- Recorded with a yes and no response.
- Measured in minutes (recorded in the patient's monitoring sheet).
- Measured in minutes (self-reported by the patient).
- Measured in minutes (self-reported by the patient).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tthree groups of patients, each with 12 patients: 1. opioid based aneshesia (OBA) 2. opioid-free anesthesia with thoracic paravertebral block (TPVB) 3. opioid free anesthesia with intravenous agents (OFA)
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVO JURISIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, IVO JURISIC, University Hospital Dubrava
- Investigators
- IVO JURISIC, MD, Study chair, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084753
- Sponsor's protocol ID
- 2023- 2301-08
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is for the data to be made available after the study is completed and the article is published. Patients will be recorded by numbers and names will be omitted due to the General Data Protection Regulation (names will be known to the researcher). Access to the data will be possible upon request by a professional and with the approval of the University Hospital Dubrava Review Board.
Publications
El Fawal MH, Mohammed DA, Abou-Abbass H, Abbas M, Tamim H, Kanawati S. Laparoscopic Sleeve Gastrectomy under Awake Paravertebral Blockade Versus General Anesthesia: Comparison of Short-Term Outcomes. Obes Surg. 2021 May;31(5):1921-1928. doi: 10.1007/s11695-020-05197-6. Epub 2021 Jan 8.
PubMed 33417101Kanawati S, Fawal H, Maaliki H, Naja ZM. Laparoscopic sleeve gastrectomy in five awake obese patients using paravertebral and superficial cervical plexus blockade. Anaesthesia. 2015 Aug;70(8):993-5. doi: 10.1111/anae.13037. Epub 2015 Mar 10.
PubMed 25756905Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.
PubMed 29077813Frey WC, Pilcher J. Obstructive sleep-related breathing disorders in patients evaluated for bariatric surgery. Obes Surg. 2003 Oct;13(5):676-83. doi: 10.1381/096089203322509228.
PubMed 14627460Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26.
PubMed 31785720Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.
PubMed 30810425Oderda GM, Senagore AJ, Morland K, Iqbal SU, Kugel M, Liu S, Habib AS. Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden. J Pain Palliat Care Pharmacother. 2019 Sep-Dec;33(3-4):82-97. doi: 10.1080/15360288.2019.1668902. Epub 2019 Oct 14.
PubMed 31609155Tashani OA, Astita R, Sharp D, Johnson MI. Body mass index and distribution of body fat can influence sensory detection and pain sensitivity. Eur J Pain. 2017 Aug;21(7):1186-1196. doi: 10.1002/ejp.1019. Epub 2017 Mar 6.
PubMed 28263427Phillips BT, Shikora SA. The history of metabolic and bariatric surgery: Development of standards for patient safety and efficacy. Metabolism. 2018 Feb;79:97-107. doi: 10.1016/j.metabol.2017.12.010. Epub 2018 Jan 5.
PubMed 29307519
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Opioid-based Anesthesia, Opioid-free Anesthesia Based on Intravenous Drugs and Opioid-free Anesthesia With Thoracic Paravertebral Block, in Patients Undergoing Laparoscopic Gastric Bypass Surgery for Obesity
- ClinicalTrials.gov ID
- NCT07084753
- Acronym / sponsor ID
- 2023- 2301-08
- Conditions
- Obese Patients, Bariatric Surgical Pain, Bariatric Surgery (Sleeve Gastrectomy ), Non-Opioid Pain Management, PONV, Postoperative Analgesia
- Keywords
- thoracic paravertebral block, obese patients, bariatric surgery, sleeve gastrectomy, postoperative pain management, anesthesia recovery period, non-opioid anesthesia, recovery after bariatric surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IVO JURISICUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. A thoracic paravertebral block is performed by inserting a needle into the intercostal spaces on the back, approximately 4 cm lateral to the spine. Many studies support excellent pain control with this technique, during and after surgery in thoracic and abdominal surgery. Investigators aim to achieve faster patient mobility after surgery, rapid recovery of bowel function, reduced nausea and vomiting, and maximum pain control. The use of opioids, which can additionally cause respiratory suppression and drowsiness, is avoided.
At any time in case of need to switch from laparoscopic to open surgery, equally adequate anesthesia and postoperative analgesia are ensured without the need to change the approach to the same. In this study, the basic scientific assumption (hypothesis) of the researchers is that non-opioid anesthesia with thoracic paravertebral block provides adequate pain control during and long-term after the surgical procedure, without the side effects of opioid anesthesia.
The main goal of the study is to determine which type of anesthesia results in the best pain control and most significantly reduces complications of anesthesia and surgery in overweight patients who are scheduled for laparoscopic longitudinal gastrectomy and partial/total gastrectomy.
Detailed description
Morbid obese patients scheduled for laparoscopic sleeve gastric resection need specific care during surgery and post-surgery. Postoperative pain management of these patients after this type of surgery is a challenge because of the high prevalence of nausea, vomiting, and higher risk of respiratory depression in obese patients, making the use of opioids undesirable. Various techniques have been used during and after surgery to control moderate to severe pain for early mobilization: OFA (opioid-free anesthesia) based on intravenous use of dexmedetomidine, ketamine, and lidocaine, or OBA (opioid-based anesthesia) in combination with regional anesthesia, to reduce the use of opioids. Regional anesthesia can be used as an additional modality of analgesia within OFA (opioid-free anesthesia) or opioid-based anesthesia (OBA), which either completely avoid the use of opioids or significantly reduce them. Investigators will compare opioid-based general anesthesia (OBA group) as the standard of anesthesia for bariatric surgery with intraoperative opioid- free anesthesia based on thoracic paravertebral block (TPVB group) and intraoperative opioid-free anesthesia based on intravenous dexmedetomidine, ketamine, and lidocaine (OFA group). The primary objective is to compare pain levels as measured by the 0-10 NRS and to compare opioid and analgesic consumption in the perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Tthree groups of patients, each with 12 patients: 1. opioid based aneshesia (OBA) 2. opioid-free anesthesia with thoracic paravertebral block (TPVB) 3. opioid free anesthesia with intravenous agents (OFA)
| Arm | Type | Receives |
|---|---|---|
| Opioid based anesthesia (OBA) | Active comparator | Drug: Sufentanil, Procedure: Opioid based Anesthesia, Drug: Metoclopramide 10mg, Drug: Ondasetron 4mg, Drug: Dexamethasone, 8 mg intravenouslyPremedication: pantoprazole 40 mg i.v. 1h before surgery. Following three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg/kg ideal body weight), and rocuronium (0.8 to 1 mg/kg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room. To prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). For pain levels of 4 or higher on a numerical rating scale (NRS), treatment options include metamizole (2.5 g), pethidine (25 to 100 mg), or tramadol (100 mg). For nausea and vomiting, intravenous doses of ondansetron or metoclopramide are provided as needed. |
| Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine | Active comparator | Drug: Dexmedetomidin, Drug: ketamine, Drug: Lidocain, Procedure: Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine, Drug: Thiethylperazine, Drug: Dexamethasone, 8 mg intravenouslyPremedication: pregabalin 75 mg peroraly et pantoprazole 40mg i.v. A pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. After this initial period, anesthetic induction is conducted using propofol at a dose of 1-2 mg/kg IBW and rocuronium at 0.8-1 mg/kg IBW. Anesthesia is sustained with sevoflurane maintained at 0.5-1 MAC, adjusted per BIS readings. The anesthetic mixture was maintained at a rate of 5-10 ml per hour adjusted according to the patient's blood pressure and pulse. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). To prevent nausea and vomiting, patients receive intraoperative dexamethasone 8 mg and thiethylperazine 6.5 mg intravenously. |
| Opioid free anesthesia based on thoracic paravertebral block (TPVB) | Experimental | Drug: Levobupivacaine, Drug: Dexamethasone contained in the solution for thoracic paravertebral block, Drug: Adrenaline, Procedure: Opioid free anesthesia based on thoracic paravertebral block, Device: Ultrasound guided thoracic paravertebral block, Device: Nerve stimulator for peripheral nerve blocks, Drug: Metoclopramide 10mgPremedication: pantoprazol 40mg i.v. Preoperative TPVB is executed at the Th5, Th7, and Th9 levels bilaterally. The skin at each level are infiltrated with 1.5 ml of 1% lidocaine. Subsequently, 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level and flushed with 1 ml of 5% glucose. In the operating room a induction is carried out with propofol administered at a dosage of 2-2.5 mg/kg of ideal body weight (IBW) and rocuronium at 0.8-1 mg/kg of IBW. Anesthesia is maintained with an infusion of propofol at 100 mcg/kg of total body weight (TBW) per minute, with adjustments made to achieve a targeted BIS value between 40-60. Intraoperative pain management includes metamizole (2.5 g) and acetaminophen (1 g). Prophylaxis of PONV is dexamethasone 8 mg previously administered within the thoracic paravertebral block, with intraoperative administration of 10 mg metoclopramide. Completely opioid-free interventions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)
- body mass index of 30 kg/m² or greater
- patients classified as ASA status 2-3.
Key exclusion criteria (14 listed)
- allergies to the intended medications
- patient refusal
- uncontrolled psychiatric disorders
- intracranial pathology
- cerebrovascular damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineUsed in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline). | Drug | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| Dexamethasone contained in the solution for thoracic paravertebral blockUsed in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline). | Drug | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| AdrenalineUsed in thoracic paravertebral block: 10 ml of 0.33% levobupivacaine, combined with 1.33 mg of dexamethasone and 40 mcg of adrenaline, is injected at each level (six levels, at the Th5, Th7, and Th9 levels bilaterally; a total of 200 mg of levobupivacaine, 8 mg of dexamethasone and 240 mcg of adrenaline). | Drug | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| DexmedetomidinA pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour. | Drug | Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
| ketamineA pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour. | Drug | Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
| LidocainA pre-prepared 50 ml syringe is utilized, containing 400 mcg of dexmedetomidine (4 ml), 50 mg of S-ketamine (2 ml), 400 mg of 2% lidocaine (20 ml), and 0.9% NaCl to a total volume of 40 ml. Anesthesia is commenced with the infusion from syringe 1 over a 10-minute period at a rate of 15 ml/hour. The anesthetic mixture was maintained at a rate of 5-10 ml per hour. | Drug | Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
| SufentanilFollowing three-minute preoxygenation, sufentanil (5 to 15 micrograms), propofol (1 to 2 mg/kg ideal body weight), and rocuronium (0.8 to 1 mg/kg ideal body weight) are administered intravenously during induction of anesthesia. Anesthesia is sustained with sevoflurane maintained at 0.6-1.3 MAC. Sufentanil is added at the assessment of the anesthesiologist in the operating room. | Drug | Opioid based anesthesia (OBA) |
| Opioid free anesthesia based on thoracic paravertebral blockAlso: OFA based on TPVBPatients scheduled for laparoscopic sleeve gastrectomy will be anesthetized without the use of opioids, with general anesthesia and pain blockade using a thoracic paravertebral block | Procedure or surgery | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| Opioid based AnesthesiaPatients scheduled for laparoscopic sleeve gastrectomy will be anesthetized with opioids and general anesthesia | Procedure or surgery | Opioid based anesthesia (OBA) |
| Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaineAlso: OFAPatients who are scheduled for laparoscopic gastrectomy will be anesthetized without the use of opioids and under general anesthesia, with analgesia by intravenous administration of dexmedetomidine, ketamine and lidocaine. | Procedure or surgery | Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
| Ultrasound guided thoracic paravertebral blockAlso: Ultrasound guided TPVBPatients are positioned prone, with the identification of the 1st rib achieved using a convex XX Hz ultrasound probe. The left and right transverse processes of the 5th, 7th, and 9th thoracic vertebrae are marked accordingly. TPVB is executed in a paramedian sagittal oblique scan utilizing an in-plane needle insertion approach at the Th5, Th7, and Th9 levels bilaterally. An insulated echogenic needle, sized between 10-15 cm and 22-20 G, is employed. The skin and subcutaneous tissue at each level are infiltrated with 1.5 ml of 1% lidocaine. Ultrasound guidance combined with nerve stimulation (dual monitoring) is utilized at each corresponding paravertebral space. Verification of the paravertebral space is established through visualization of pleural displacement, as observed via the ultrasound probe following the injection of 1 ml of 5% glucose, as well as via a motor response at a current intensity of 0.3-0.5 mA. | Device | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| Nerve stimulator for peripheral nerve blocksDuring the application of the thoracic paravertebral block, verification of the distance of the insulated echogenic needle tip from the thoracic spinal nerve is monitored using via a motor response at a current intensity of 0.3-0.5 mA. | Device | Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| Metoclopramide 10mgTo prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and metoclopramide (10 mg) intraoperatively | Drug | Opioid based anesthesia (OBA), Opioid free anesthesia based on thoracic paravertebral block (TPVB) |
| Ondasetron 4mgTo prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intraoperatively. | Drug | Opioid based anesthesia (OBA) |
| ThiethylperazineTo prevent postoperative nausea and vomiting (PONV), patients receive dexamethasone (8 mg) and thiethylperazine (6.5 mg) intravenously. | Drug | Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
| Dexamethasone, 8 mg intravenouslyTo prevent postoperative nausea and vomiting (PONV), patients receive intraoperatively dexamethasone (8 mg), ondansetron (4 mg), and metoclopramide (10 mg) intravenously. | Drug | Opioid based anesthesia (OBA), Opioid free anesthesia (OFA) based on lidocain, dexmedetomidine and S-ketamine |
Primary outcome
a) Postoperative pain levels measured by the 0-10 Numerical rating scale (NRS). b) Opioid analgesic consumption (Morphine milligram equivalents- MME).
Time frame: 10 days
1. Self-reported pain levels recorded at multiple time points:30 minutes post- surgery, every three hours for the first 24 hours, and three times daily for the following nine days. Zero indicates no pain, ten is the worst possible pain. 2. Use of opioids (sufentanil, pethidine, tramadol) before, during and after surgery. Sufentanil in micrograms, pethidine and tramadol in milligrams. Values are converted into Morphine milligram equivalents (MME),
1 secondary outcome
a) Self-reported incidence of PONV after surgery. b) Time in the postoperative care unit (PACU) after surgery. c) Time to first mobilization after surgery. d) Time to fluid intake after surgery.
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 33417101El Fawal MH, Mohammed DA, Abou-Abbass H, Abbas M, Tamim H, Kanawati S. Laparoscopic Sleeve Gastrectomy under Awake Paravertebral Blockade Versus General Anesthesia: Comparison of Short-Term Outcomes. Obes Surg. 2021 May;31(5):1921-1928. doi: 10.1007/s11695-020-05197-6. Epub 2021 Jan 8.
- Background: PubMed 25756905Kanawati S, Fawal H, Maaliki H, Naja ZM. Laparoscopic sleeve gastrectomy in five awake obese patients using paravertebral and superficial cervical plexus blockade. Anaesthesia. 2015 Aug;70(8):993-5. doi: 10.1111/anae.13037. Epub 2015 Mar 10.
- Background: PubMed 29077813Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.
- Background: PubMed 14627460Frey WC, Pilcher J. Obstructive sleep-related breathing disorders in patients evaluated for bariatric surgery. Obes Surg. 2003 Oct;13(5):676-83. doi: 10.1381/096089203322509228.
- Background: PubMed 31785720Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26.
- Background: PubMed 30810425Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.
- Background: PubMed 31609155Oderda GM, Senagore AJ, Morland K, Iqbal SU, Kugel M, Liu S, Habib AS. Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden. J Pain Palliat Care Pharmacother. 2019 Sep-Dec;33(3-4):82-97. doi: 10.1080/15360288.2019.1668902. Epub 2019 Oct 14.
- Background: PubMed 28263427Tashani OA, Astita R, Sharp D, Johnson MI. Body mass index and distribution of body fat can influence sensory detection and pain sensitivity. Eur J Pain. 2017 Aug;21(7):1186-1196. doi: 10.1002/ejp.1019. Epub 2017 Mar 6.
- Background: PubMed 29307519Phillips BT, Shikora SA. The history of metabolic and bariatric surgery: Development of standards for patient safety and efficacy. Metabolism. 2018 Feb;79:97-107. doi: 10.1016/j.metabol.2017.12.010. Epub 2018 Jan 5.
- Individual participant dataSharing planned: Yes. The plan is for the data to be made available after the study is completed and the article is published. Patients will be recorded by numbers and names will be omitted due to the General Data Protection Regulation (names will be known to the researcher). Access to the data will be possible upon request by a professional and with the approval of the University Hospital Dubrava Review Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IVO JURISIC, MD study chair
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine, Dexamethasone contained in the solution for thoracic paravertebral block and Adrenaline in people with Obese Patients and Bariatric Surgical Pain, run by IVO JURISIC at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IVO JURISIC, MD (+385989050015, i.jurisic.kbd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) Postoperative pain levels measured by the 0-10 Numerical rating scale (NRS). b) Opioid analgesic consumption (Morphine milligram equivalents- MME). (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084753, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.