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General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
general anesthesia
Paravertebral block
Placebo PVB
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GA+PVB

GA+placebo PVB

Arm Description

Patients will receive general anesthesia with paravertebral block

Patients will receive general anesthesia with placebo block

Outcomes

Primary Outcome Measures

postoperative pain
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.

Secondary Outcome Measures

ambulation
The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire

Full Information

First Posted
March 3, 2018
Last Updated
September 26, 2019
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03469700
Brief Title
General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy
Official Title
General Anesthesia vs Paravertebral Block With General Anesthesia For Post-Operative Pain Post Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GA+PVB
Arm Type
Experimental
Arm Description
Patients will receive general anesthesia with paravertebral block
Arm Title
GA+placebo PVB
Arm Type
Active Comparator
Arm Description
Patients will receive general anesthesia with placebo block
Intervention Type
Other
Intervention Name(s)
general anesthesia
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Paravertebral block
Intervention Description
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%
Intervention Type
Other
Intervention Name(s)
Placebo PVB
Intervention Description
Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.
Primary Outcome Measure Information:
Title
postoperative pain
Description
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.
Time Frame
within 1 week postoperatively
Secondary Outcome Measure Information:
Title
ambulation
Description
The secondary aim is to assess the time of first movement (early ambulation) between both groups. This will be assessed via a questionnaire
Time Frame
within 1 week postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saleh Kanawati, MD
Phone
+9611636000
Ext
6405
Email
s.kanawati@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saleh Kanawati, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleh Kanawati, MD
Phone
+9611636000
Ext
6405
Email
s.kanawati@hotmail.com

12. IPD Sharing Statement

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General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy

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