ESPB With Dexmetomidine May Provide AnalgesiaNCT07380503
Analgesic Efficacy of Adding Different Doses of Dexmedetomidine as Adjuvants With Bupivacaine vs.Bupivacaine Only in Ultrasound-guided Erector Spinae Plane Block in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery. A Randomized Controlled Double Blinded Study.
An observational study of ESPB With Dexmetomidine May Provide Analgesia, run by Cairo University at 1 site in Egypt.
Trial summary
Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine only in ultrasound-guided erector spinae plane block in morbidly obese patients undergoing Laparoscopic Bariatric surgery. A RANDOMIZED CONTROLLED DOUBLE BLINDED STUDY. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ESPB With Dexmetomidine May Provide Analgesia
- What is being tested?
- Analgesic Efficacy of adding different doses of dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 15 Oct 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: The Patients were assessed the day before surgery in a preoperative visit for evaluation of their medical status, laboratory investigations and for fulfilling all the above inclusion and exclusion criteria. 20g cannula inserted in holding area. Premedication with 0.02 mg/kg midazolam was administered intravenously 5 minutes before block performance.
Who may be able to join
- Age starting from 21 to 60 years.
- Genders eligible for study: Male and female sexes.
- ASA I-III
- Undergoing Laparoscopic bariatric surgery.
- BMI > = 40.
Who cannot join
- Patient refusal
- Known allergy to local anesthetics and adjuvant drugs used (dexamedatomedine)
- Bleeding disorders; platelets count <50,000, prothrombin concentration < 60% or any coagulopathy disorder.
- Use of any anti-coagulants
- Inability to provide informed consent
- ASA -IV
Show all 9Show fewer
- Neurological disorders
- Patient with psychiatric disorders
- Failed block is claimed if the patient required more than 2 doses of rescue analgesia in the first 2 hrs post operative , failed block cases will be recorded , excluded and managed according to the institutional regulations (opioid analgesia).
Trial locations and contacts
1 site in 1 country.
About this study
Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine only in ultrasound-guided erector spinae plane block in morbidly obese patients undergoing Laparoscopic Bariatric surgery. A RANDOMIZED CONTROLLED DOUBLE BLINDED STUDY.
Read the detailed description
Bariatric surgery is recognized as an essential and effective treatment for obesity and relevant metabolic diseases, such as type 2 diabetes . With the promotion of enhanced recovery after surgery (ERAS) in bariatric surgery, the administration of the ERAS protocol has been widely accepted . Compared with traditional treatment, ERAS reduces the potential opportunity for postoperative complications, ultimately improving the quality of care for patients . Inadequate postoperative pain management for patients may increase the amount of opioid analgesic drugs consumed, prolong time to off-bed activity and hospitalization, augment the incidence of relevant complications, increase medical costs, and reduce the quality of life Laparoscopic bariatric surgeries are considered minimally invasive procedures, but they can cause severe pain . Opioids are excellent analgesics, but they have many side effects as respiratory depression, which may further complicate pain management in bariatric surgeries, particularly in cases with obstructive sleep apnea . Other comorbidities such as diabetes mellitus and cardiovascular diseases that are common in patients with obesity can also lead to difficulties with pain management . This complexity highlights the challenges of the optimal choice of analgesia in bariatric surgery.
The new regional blocking technique (Erector spinae plane block) can utilize to reduce postoperative pain effectively in various surgical procedures such as breast, thoracic, abdominal and lumbar surgery . However, although usually the use of long-acting local anesthetics (LAs), not provide long duration of action . Even though continuous catheter-based nerve block can prolong the postoperative pain relief time, this technique requires additional time and cost, and increases the risk of infection and neurological complications Dexmedetomidine (DEX) is a highly selective alpha-2 adrenergic receptor agonist with sedative and analgesic sparing effects, reduced delirium and agitation, with additive perioperative sympatholysis, cardiovascular stabilizing effects, and preservation of respiratory function..
In previous clinical studies, DEX as adjuvant to LAs as the potential to prolong blockade duration. However, it remains unclear whether Dex as an adjunct for bupivicaine to ESPB can significantly improve the quality of postoperative analgesia and recovery after Laproscopic bariatric surgery in morbidly obese patients. Thus, the main objective of the present study was to explore the effects of different dosages of Dex as an adjunct for bupivicaine combined with ESPB on the quality of postoperative analgesia and recovery and achieve opioid free anasthesia in patients following laproscopic bariatric surgery
- Being tested
- Analgesic Efficacy of adding different doses of dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic Efficacy of adding different doses of dexmedetomidineDrug
Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (ESPB alone) | The block was performed with full aseptic precautions. A convex ultrasound probe was wrapped in a sterile lens sleeve, and the sagittal side position of the probe (approximately 3 cm) was used to locate the bilateral T7 transverse process. We used an in-plane needle technique, inserting a 21-gauge needle (Sonoplex cannula)+ into the surface of the transverse process in a caudal to cranial direction. There was no blood or cerebrospinal fluid while withdrawing the syringe plunger. Saline (3 mL) was injected between the erector spinae muscle and the transverse process for hydrodissection to confirm the correct position., 20 mL of 0.25% bupivacaine was administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spine muscle is an indication of a successful puncture. Receives: Drug: Analgesic Efficacy of adding different doses of dexmedetomidine | |
| Group 2 (ESPB with dexamedatomedine 1 mcg/kg) | The erectospinae plane block was performed bilaterally with 20 ml 0.25 % bupivacaine prepared as follows: 10 ml bupivacaine 0.5% + 1 mcg per kg dexmedatomidine (2ml)+ 8 ml normal saline Receives: Drug: Analgesic Efficacy of adding different doses of dexmedetomidine | |
| Group 3 (ESPB with dexamedatomedine (1.5 mcg/kg) | The erectospinae plane block was performed bilaterally with 20 ml 0.25 % bupivacaine prepared as follows: 10 ml bupivacaine 0.5% + 1.5 mcg per kg dexmedatomidine (2ml)+ 8 ml normal saline Receives: Drug: Analgesic Efficacy of adding different doses of dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption in Day 1
Postoperative opioid consumption in Day 1
Measured: Day 1
Secondary outcomes (9)
Visual Analogue Scale
Visual Analogue Scale (VAS) pain score assessed immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h. Scores (1-3) were considered mild pain, (4-6) moderate pain and (7-10) severe pain
Measured: Ffirst day
Time to first postoperative rescue analgesia
Total dose of fentanyl required intraoperative (including induction dose) to be 200 microgram
Measured: Time to first postoperative rescue analgesia in one day
Ramzy sedation score:
- Score 1:Awake;agitated or restless or both.
- Score 2: Awake; cooperative, oriented and tranquil.
- Score 3: Awake but responds to commands only
- Sore 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus.
- Score 5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus
- Score 6: Asleep; no response to glabellar tap or loud auditory stimulus
Measured: Day 1
Effect on arterial blood pressure
Effect on arterial blood pressure
Measured: Day 1
Number and percentage of people developing side effects of block (pneumothorax, vascular injury).
Number and percentage of people developing side effects of block (pneumothorax, vascular injury).
Measured: Day 1
Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.
Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.
Measured: Through Study Completion
Local anesthetic toxicity.
Local anesthetic toxicity
Measured: Through Study Completion
Post operative nausea and vomiting.
Post operative nausea and vomiting.
Measured: Through Study Completion
Effect on heart rate
Effect on heart rate
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2025
- Primary completion30 Aug 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESPB With Dexmetomidine May Provide AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Abdalla Mohamed Ali Nasr, Dina Soliman Mohammed Idris, Mohamed Nabil Elshafie Abdulkader, Mohamed Ahmed Abd El Hamed Shamma, Aya Sayed Ali Ahmed Mostafa
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380503
- Sponsor's protocol ID
- MD-402-2024
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When study completed
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Adding Different Doses of Dexmedetomidine as Adjuvants With Bupivacaine vs.Bupivacaine Only in Ultrasound-guided Erector Spinae Plane Block in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery. A Randomized Controlled Double Blinded Study.
- ClinicalTrials.gov ID
- NCT07380503
- Acronym / sponsor ID
- MD-402-2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ahmed Abdalla Mohamed Ali Nasr, Dina Soliman Mohammed Idris, Mohamed Nabil Elshafie Abdulkader, Mohamed Ahmed Abd El Hamed Shamma, Aya Sayed Ali Ahmed Mostafa
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 2 Feb 2026 (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.
Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine only in ultrasound-guided erector spinae plane block in morbidly obese patients undergoing Laparoscopic Bariatric surgery. A RANDOMIZED CONTROLLED DOUBLE BLINDED STUDY.
Detailed description
Bariatric surgery is recognized as an essential and effective treatment for obesity and relevant metabolic diseases, such as type 2 diabetes . With the promotion of enhanced recovery after surgery (ERAS) in bariatric surgery, the administration of the ERAS protocol has been widely accepted . Compared with traditional treatment, ERAS reduces the potential opportunity for postoperative complications, ultimately improving the quality of care for patients . Inadequate postoperative pain management for patients may increase the amount of opioid analgesic drugs consumed, prolong time to off-bed activity and hospitalization, augment the incidence of relevant complications, increase medical costs, and reduce the quality of life Laparoscopic bariatric surgeries are considered minimally invasive procedures, but they can cause severe pain . Opioids are excellent analgesics, but they have many side effects as respiratory depression, which may further complicate pain management in bariatric surgeries, particularly in cases with obstructive sleep apnea . Other comorbidities such as diabetes mellitus and cardiovascular diseases that are common in patients with obesity can also lead to difficulties with pain management . This complexity highlights the challenges of the optimal choice of analgesia in bariatric surgery.
The new regional blocking technique (Erector spinae plane block) can utilize to reduce postoperative pain effectively in various surgical procedures such as breast, thoracic, abdominal and lumbar surgery . However, although usually the use of long-acting local anesthetics (LAs), not provide long duration of action . Even though continuous catheter-based nerve block can prolong the postoperative pain relief time, this technique requires additional time and cost, and increases the risk of infection and neurological complications Dexmedetomidine (DEX) is a highly selective alpha-2 adrenergic receptor agonist with sedative and analgesic sparing effects, reduced delirium and agitation, with additive perioperative sympatholysis, cardiovascular stabilizing effects, and preservation of respiratory function..
In previous clinical studies, DEX as adjuvant to LAs as the potential to prolong blockade duration. However, it remains unclear whether Dex as an adjunct for bupivicaine to ESPB can significantly improve the quality of postoperative analgesia and recovery after Laproscopic bariatric surgery in morbidly obese patients. Thus, the main objective of the present study was to explore the effects of different dosages of Dex as an adjunct for bupivicaine combined with ESPB on the quality of postoperative analgesia and recovery and achieve opioid free anasthesia in patients following laproscopic bariatric surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (ESPB alone) | – | Drug: Analgesic Efficacy of adding different doses of dexmedetomidineThe block was performed with full aseptic precautions. A convex ultrasound probe was wrapped in a sterile lens sleeve, and the sagittal side position of the probe (approximately 3 cm) was used to locate the bilateral T7 transverse process. We used an in-plane needle technique, inserting a 21-gauge needle (Sonoplex cannula)+ into the surface of the transverse process in a caudal to cranial direction. There was no blood or cerebrospinal fluid while withdrawing the syringe plunger. Saline (3 mL) was injected between the erector spinae muscle and the transverse process for hydrodissection to confirm the correct position., 20 mL of 0.25% bupivacaine was administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spine muscle is an indication of a successful puncture. |
| Group 2 (ESPB with dexamedatomedine 1 mcg/kg) | – | Drug: Analgesic Efficacy of adding different doses of dexmedetomidineThe erectospinae plane block was performed bilaterally with 20 ml 0.25 % bupivacaine prepared as follows: 10 ml bupivacaine 0.5% + 1 mcg per kg dexmedatomidine (2ml)+ 8 ml normal saline |
| Group 3 (ESPB with dexamedatomedine (1.5 mcg/kg) | – | Drug: Analgesic Efficacy of adding different doses of dexmedetomidineThe erectospinae plane block was performed bilaterally with 20 ml 0.25 % bupivacaine prepared as follows: 10 ml bupivacaine 0.5% + 1.5 mcg per kg dexmedatomidine (2ml)+ 8 ml normal saline |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The Patients were assessed the day before surgery in a preoperative visit for evaluation of their medical status, laboratory investigations and for fulfilling all the above inclusion and exclusion criteria. 20g cannula inserted in holding area. Premedication with 0.02 mg/kg midazolam was administered intravenously 5 minutes before block performance.
Key inclusion criteria (5 listed)
- Age starting from 21 to 60 years.
- Genders eligible for study: Male and female sexes.
- ASA I-III
- Undergoing Laparoscopic bariatric surgery.
- BMI > = 40.
Key exclusion criteria (9 listed)
- Patient refusal
- Known allergy to local anesthetics and adjuvant drugs used (dexamedatomedine)
- Bleeding disorders; platelets count <50,000, prothrombin concentration < 60% or any coagulopathy disorder.
- Use of any anti-coagulants
- Inability to provide informed consent
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 |
|---|---|---|
| Analgesic Efficacy of adding different doses of dexmedetomidineAnalgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine | Drug | Group 1 (ESPB alone), Group 2 (ESPB with dexamedatomedine 1 mcg/kg), Group 3 (ESPB with dexamedatomedine (1.5 mcg/kg) |
Primary outcome
Postoperative opioid consumption in Day 1
Time frame: Day 1
Postoperative opioid consumption in Day 1
9 secondary outcomes
Visual Analogue Scale
Time frame: Ffirst day
Time to first postoperative rescue analgesia
Time frame: Time to first postoperative rescue analgesia in one day
Ramzy sedation score:
Time frame: Day 1
Effect on arterial blood pressure
Time frame: Day 1
Number and percentage of people developing side effects of block (pneumothorax, vascular injury).
Time frame: Day 1
Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.
Time frame: Through Study Completion
Local anesthetic toxicity.
Time frame: Through Study Completion
Post operative nausea and vomiting.
Time frame: Through Study Completion
Effect on heart rate
Time frame: Day 1
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 9 Mar 2026.
- Individual participant dataSharing planned: Undecided. When study completed
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESPB With Dexmetomidine May Provide Analgesia, run by Cairo 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 5 inclusion and 9 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 9 Mar 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?
Postoperative opioid consumption in Day 1 (time frame: Day 1). 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 9 Mar 2026.