- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03469700
General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy
September 26, 2019 updated by: Saleh Kanawati, Makassed General Hospital
General Anesthesia vs Paravertebral Block With General Anesthesia For Post-Operative Pain Post Laparoscopic Sleeve Gastrectomy
The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity.
We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomized, double-blind controlled clinical trial.
Written informed consent will be obtained from patients.
Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beirut, Lebanon
- Recruiting
- Makassed General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with body mass index (BMI) greater than or equal to 30
- American Society of Anesthesiologist (ASA) score greater than or equal to 2
- Undergoing laparoscopic gastric sleeve surgeries
Exclusion Criteria:
- Patients with ASA score less than 2 and greater than 4
- Patients with any type of allergy to local anesthesia
- Patients refusing to be part of the study (refusal to sign consent)
- Any complication during surgery or anesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GA+PVB
Patients will receive general anesthesia with paravertebral block
|
Induction of general anesthesia will be performed followed by endotracheal intubation.
General anesthesia is induced with 0.5-1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam.
Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex.
Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.6 mg/kg/h rocuronium, 60% nitrous oxide and 40% oxygen with Ultiva (Remifentanyl) 0.1-0.2
μg/kg/hr
Bilateral paravertebral block guided by a nerve stimulator will be performed by injecting local anesthetic mixture from levels T11 to T6.
Each 20 ml of the mixture will contain: 6 ml lidocaine 2%; 6 ml lidocaine 2% with adrenaline 5 μg /ml; 5 ml bupivacaine 0.5%; 50μg fentanyl (1 ml); and 2 ml saline 0.9%
|
Active Comparator: GA+placebo PVB
Patients will receive general anesthesia with placebo block
|
Induction of general anesthesia will be performed followed by endotracheal intubation.
General anesthesia is induced with 0.5-1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam.
Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex.
Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.6 mg/kg/h rocuronium, 60% nitrous oxide and 40% oxygen with Ultiva (Remifentanyl) 0.1-0.2
μg/kg/hr
Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain
Time Frame: within 1 week postoperatively
|
The primary aim is to compare the effect of paravertebral block with general anesthesia versus general anesthesia alone on postoperative pain after laparoscopic sleeve gastrectomy surgeries.
Pain will be assessed using the Visual Analogue scale (VAS) with a score of 0 denoting no pain and 10 maximum possible pain.
|
within 1 week postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ambulation
Time Frame: within 1 week postoperatively
|
The secondary aim is to assess the time of first movement (early ambulation) between both groups.
This will be assessed via a questionnaire
|
within 1 week postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
March 3, 2018
First Submitted That Met QC Criteria
March 16, 2018
First Posted (Actual)
March 19, 2018
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 26, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15218
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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