- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141955
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy
A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Ain-Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Erector Spinae Plane Block (ESPB)
|
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 "
|
|
Active Comparator: Group Quadratus Lumborum Block (QLB)
|
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 "
|
|
Other: Group (C) (Control group)
|
Where patients will be operated under general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first requested rescue analgesia(Minutes)
Time Frame: 24 hours postoperatively
|
Time to first requested rescue analgesia(Minutes)
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS 705/ 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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