Laparoscopic Sleeve Gastrectomy (LSG)NCT06798103
Comparing Perioperative Analgesia After Ultrasound Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block in Laparoscopic Sleeve Gastrectomy Patients
A study testing Erector Spinae Plane Block and Thoracic paravertebral block in people with Laparoscopic Sleeve Gastrectomy (LSG) and Erector Spinae Plane Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy of ultrasound-guided bilateral erector spinae plane block and thoracic paravertebral block on perioperative analgesic control for 24 hours postoperative and fast recovery of patients undergoing laparoscopic sleeve gastrectomy using the Visual Analogue Scale. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy (LSG), Erector Spinae Plane Block, Thoracic Paravertebral Block
- What is being tested?
- Erector Spinae Plane Block and Thoracic paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 21 to 60 years.
- Sex: males and females
- Patients with American Society of Anesthesiologists physical status 4.classifications II-III undergoing laparoscopic sleeve gastrectomy under general anaesthesia.
Who cannot join
- Patient refusing to participate in the study.
- Patients with bleeding disorders.
- A history of relevant local anaesthetic allergy.
- Patients with muscle diseases.
- Evidence of local infection at site of injection.
- Pre-existing chronic pain or cognitive dysfunction (which would impede accurate engagement with postoperative quality of recovery and analgesia assessment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Efficacy of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block on Perioperative Analgesia and Fast Recovery of Patients Undergoing Laparoscopic Sleeve Gastrectomy
The aim of this study is to compare the efficacy of ultrasound-guided bilateral erector spinae plane block and thoracic paravertebral block on perioperative analgesic control for 24 hours postoperative and fast recovery of patients undergoing laparoscopic sleeve gastrectomy using the Visual Analogue Scale.
Read the detailed description
Obesity was ranked as the 5th preventable cause of death and is associated with certain diseases as non-insulin dependent diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO).
Bariatric surgery has been advocated for adults with severe obesity for weight reduction purposes and lowering the health risks linked to obesity. Laparoscopic sleeve gastrectomy (LSG) is considered an efficient approach to bariatric surgery which provides an apparent weight loss and an improved weight-related quality of life with reduced postoperative morbidity but is frequently complicated by moderate to severe pain especially in the immediate postoperative period.
The Enhanced Recovery After Surgery (ERAS) recommendations for bariatric surgery currently advocate the utilization of regional anesthesia techniques, which constitute a valuable component of opioid sparing multimodal analgesia strategies to reduce intraoperative and postoperative narcotics consumption. Poorly controlled postsurgical pain is linked to decreased quality of care, surgical complications, prolonged immobility, rehabilitation and hospitalization, development of chronic pain, higher treatment costs, and a heavy burden on the healthcare system.
In 2016, the ultrasound (US)-guided erector spinae plane block (ESPB) was first described to treat thoracic neuropathic pain. The ESPB local anesthetic injectant into the fascial plane deep to the erector spinae muscle with craniocaudal distribution has an analgesic impact on somatic and visceral pain. It causes both somatic and visceral sensory blockade via acting on the ventral and dorsal rami of spinal nerves. The ESPB can provide analgesia to abdominal operations performed at a lower thoracic vertebral level (T7 or T8). However, the main concern with the ESPB is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.
Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain through injecting local anaesthetic alongside the thoracic vertebrae and close to where the spinal nerves emerge from the intervertebral foramen. It produces ipsilateral, somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes that culminate in high-quality afferent nociceptive blockade. Despite its wide use in thoracic procedures, to date, few studies have assessed the effectiveness of Thoracic paravertebral block (TPVB) in laparoscopic abdominal surgeries in an adult population.
Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption and length of hospital stay in patients undergoing laparoscopic sleeve gastrectomy.
- Conditions
- Laparoscopic Sleeve Gastrectomy (LSG), Erector Spinae Plane Block, Thoracic Paravertebral Block
- Being tested
- Erector Spinae Plane Block, Thoracic paravertebral block
- Keywords
- Laparoscopic Sleeve Gastrectomy (LSG), Erector Spinae Plane Block, Thoracic Paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Also called ESPB
Erector spinae plane block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved to a parasagittal plane to visualize skin and subcutaneous tissue layers, trapezius muscle, and lastly the erector spinae muscle just superficial to the transverse processes. The in-plane technique will be used, and the tip of the needle will be inserted in the fascial plane deep to the erector spinae muscle. After 2-3 mL of normal saline injection for hydro dissection to verify the correct needle tip placement, 30 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle. The same technique will be repeated on the contralateral side.
Thoracic paravertebral blockProcedure or surgery
Also called TPVB
Thoracic paravertebral block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved 3-5 cm laterally to identify the paravertebral space as the target injection site. After probe being rotated into transverse orientation, the needle will be inserted using the out-plane technique. Once the needle threads the internal intercostal membrane and arrives in the paravertebral space, 3 ml of normal saline will be injected firstly. If displacement sign of the pleura occurs, 25 ml of 0.25% bupivacaine will be then injected into the confirmed paravertebral space. The same technique will be repeated on the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group (ESPB) | Active comparator | Group (I): 15 participants will be injected with 30 mL of 0.25% bupivacaine deep to the erector spinae muscle. Receives: Procedure: Erector Spinae Plane Block |
| Thoracic paravertebral block group (TPVB) | Active comparator | Group (II): 15 participants will be injected with 25 ml of 0.25% bupivacaine into paravertebral space of T7 vertebra. Receives: Procedure: Thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first Rescue Analgesia
25 mg IV Meperidine (Pethidine) will be given as a rescue analgesia if patients complained of postoperative pain and their Visual Analogue Scale for pain ≥ 3 and to be repeated if patients continue to complain. Time to first rescue analgesia will be recorded.
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient will be asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Measured: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery and Meperidine will be given accordingly.
Secondary outcomes (6)
mean Meperidine consumption
The total requirements of rescue analgesia (Meperidine) over the first 24 hours postoperative will be recorded as mean Meperidine consumption.
Measured: 24 hours postoperatively
Heart rate
changes in heart rate will be recorded.
Measured: 24 hours postoperatively
Visual Analogue Scale for pain
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient will be asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Measured: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery.
Time to perform the block
Time taken by the investigator to perform the block.
Measured: Time needed to perform the block intraoperative before induction of general anaesthesia will be recorded.
Time to first ambulation
The time taken by the patients to start ambulation after recovery from general anaesthesia.
Measured: 24 hours postoperatively
Systolic, Diastolic and Mean arterial blood pressures
changes in systolic, diastolic and mean arterial blood pressure will be recorded
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Sleeve Gastrectomy (LSG)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Ahmed Ahmed, Ain Shams University
- Investigators
- Farouk Kamaleldin Abdelaziz, MD, Lecturer, Principal investigator, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798103
- Sponsor's protocol ID
- FMASU MD335/2023
- Status last verified
- Feb 2025
- First submitted
- 3 Jan 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Efficacy of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block on Perioperative Analgesia and Fast Recovery of Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06798103
- Acronym / sponsor ID
- FMASU MD335/2023
- Conditions
- Laparoscopic Sleeve Gastrectomy (LSG), Erector Spinae Plane Block, Thoracic Paravertebral Block
- Keywords
- Laparoscopic Sleeve Gastrectomy (LSG), Erector Spinae Plane Block, Thoracic Paravertebral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 29 Jan 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.
The aim of this study is to compare the efficacy of ultrasound-guided bilateral erector spinae plane block and thoracic paravertebral block on perioperative analgesic control for 24 hours postoperative and fast recovery of patients undergoing laparoscopic sleeve gastrectomy using the Visual Analogue Scale.
Detailed description
Obesity was ranked as the 5th preventable cause of death and is associated with certain diseases as non-insulin dependent diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO).
Bariatric surgery has been advocated for adults with severe obesity for weight reduction purposes and lowering the health risks linked to obesity. Laparoscopic sleeve gastrectomy (LSG) is considered an efficient approach to bariatric surgery which provides an apparent weight loss and an improved weight-related quality of life with reduced postoperative morbidity but is frequently complicated by moderate to severe pain especially in the immediate postoperative period.
The Enhanced Recovery After Surgery (ERAS) recommendations for bariatric surgery currently advocate the utilization of regional anesthesia techniques, which constitute a valuable component of opioid sparing multimodal analgesia strategies to reduce intraoperative and postoperative narcotics consumption. Poorly controlled postsurgical pain is linked to decreased quality of care, surgical complications, prolonged immobility, rehabilitation and hospitalization, development of chronic pain, higher treatment costs, and a heavy burden on the healthcare system.
In 2016, the ultrasound (US)-guided erector spinae plane block (ESPB) was first described to treat thoracic neuropathic pain. The ESPB local anesthetic injectant into the fascial plane deep to the erector spinae muscle with craniocaudal distribution has an analgesic impact on somatic and visceral pain. It causes both somatic and visceral sensory blockade via acting on the ventral and dorsal rami of spinal nerves. The ESPB can provide analgesia to abdominal operations performed at a lower thoracic vertebral level (T7 or T8). However, the main concern with the ESPB is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.
Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain through injecting local anaesthetic alongside the thoracic vertebrae and close to where the spinal nerves emerge from the intervertebral foramen. It produces ipsilateral, somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes that culminate in high-quality afferent nociceptive blockade. Despite its wide use in thoracic procedures, to date, few studies have assessed the effectiveness of Thoracic paravertebral block (TPVB) in laparoscopic abdominal surgeries in an adult population.
Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption and length of hospital stay in patients undergoing laparoscopic sleeve gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group (ESPB) | Active comparator | Procedure: Erector Spinae Plane BlockGroup (I): 15 participants will be injected with 30 mL of 0.25% bupivacaine deep to the erector spinae muscle. |
| Thoracic paravertebral block group (TPVB) | Active comparator | Procedure: Thoracic paravertebral blockGroup (II): 15 participants will be injected with 25 ml of 0.25% bupivacaine into paravertebral space of T7 vertebra. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 21 to 60 years.
- Sex: males and females
- Patients with American Society of Anesthesiologists physical status 4.classifications II-III undergoing laparoscopic sleeve gastrectomy under general anaesthesia.
Key exclusion criteria (6 listed)
- Patient refusing to participate in the study.
- Patients with bleeding disorders.
- A history of relevant local anaesthetic allergy.
- Patients with muscle diseases.
- Evidence of local infection at site of injection.
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 |
|---|---|---|
| Erector Spinae Plane BlockAlso: ESPBErector spinae plane block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved to a parasagittal plane to visualize skin and subcutaneous tissue layers, trapezius muscle, and lastly the erector spinae muscle just superficial to the transverse processes. The in-plane technique will be used, and the tip of the needle will be inserted in the fascial plane deep to the erector spinae muscle. After 2-3 mL of normal saline injection for hydro dissection to verify the correct needle tip placement, 30 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle. The same technique will be repeated on the contralateral side. | Procedure or surgery | Erector spinae plane block group (ESPB) |
| Thoracic paravertebral blockAlso: TPVBThoracic paravertebral block will be performed using an ultrasound machine with a high frequency linear probe. The patients will be in sitting position to perform the block, the skin is sterilized and the transducer will be placed across the T7 spinous process then move laterally to identify transverse process of T7. Thereafter, the probe will be moved 3-5 cm laterally to identify the paravertebral space as the target injection site. After probe being rotated into transverse orientation, the needle will be inserted using the out-plane technique. Once the needle threads the internal intercostal membrane and arrives in the paravertebral space, 3 ml of normal saline will be injected firstly. If displacement sign of the pleura occurs, 25 ml of 0.25% bupivacaine will be then injected into the confirmed paravertebral space. The same technique will be repeated on the contralateral side. | Procedure or surgery | Thoracic paravertebral block group (TPVB) |
Primary outcome
Time to first Rescue Analgesia
Time frame: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery and Meperidine will be given accordingly.
25 mg IV Meperidine (Pethidine) will be given as a rescue analgesia if patients complained of postoperative pain and their Visual Analogue Scale for pain ≥ 3 and to be repeated if patients continue to complain. Time to first rescue analgesia will be recorded. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient will be asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
6 secondary outcomes
mean Meperidine consumption
Time frame: 24 hours postoperatively
Heart rate
Time frame: 24 hours postoperatively
Visual Analogue Scale for pain
Time frame: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery.
Time to perform the block
Time frame: Time needed to perform the block intraoperative before induction of general anaesthesia will be recorded.
Time to first ambulation
Time frame: 24 hours postoperatively
Systolic, Diastolic and Mean arterial blood pressures
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Farouk Kamaleldin Abdelaziz, MD, Lecturer principal investigator
Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Thoracic paravertebral block in people with Laparoscopic Sleeve Gastrectomy (LSG) and Erector Spinae Plane Block, run by Ain Shams University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 5 Jan 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first Rescue Analgesia (time frame: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery and Meperidine will be given accordingly.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.