Back to resultsUltrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group Erector Spinae Plane Block (ESPB)
Group Quadratus Lumborum Block (QLB)
Group (C) (Control group)
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
- BMI > 35 kg/ m2
Exclusion Criteria:
- Patients unfit for surgery or refuse to sign the consent of regional block.
- Patients with known coagulation defects.
- Patients with known hypersensitivity to bupivacaine.
- Patients with infection at the site of injection.
- Conversion of laparoscopic surgery to laparotomy
Sites / Locations
- Ain-Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Group Erector Spinae Plane Block (ESPB)
Group Quadratus Lumborum Block (QLB)
Group (C) (Control group)
Arm Description
Outcomes
Primary Outcome Measures
Time to first requested rescue analgesia(Minutes)
Time to first requested rescue analgesia(Minutes)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141955
Brief Title
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official Title
A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
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
Postoperative pain control is a significant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.
The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.
The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Erector Spinae Plane Block (ESPB)
Arm Type
Active Comparator
Arm Title
Group Quadratus Lumborum Block (QLB)
Arm Type
Active Comparator
Arm Title
Group (C) (Control group)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Group Erector Spinae Plane Block (ESPB)
Intervention Description
Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg "
Intervention Type
Other
Intervention Name(s)
Group Quadratus Lumborum Block (QLB)
Intervention Description
Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg "
Intervention Type
Other
Intervention Name(s)
Group (C) (Control group)
Intervention Description
Where patients will be operated under general anesthesia.
Primary Outcome Measure Information:
Title
Time to first requested rescue analgesia(Minutes)
Description
Time to first requested rescue analgesia(Minutes)
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
BMI > 35 kg/ m2
Exclusion Criteria:
Patients unfit for surgery or refuse to sign the consent of regional block.
Patients with known coagulation defects.
Patients with known hypersensitivity to bupivacaine.
Patients with infection at the site of injection.
Conversion of laparoscopic surgery to laparotomy
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
We'll reach out to this number within 24 hrs