NCT05141955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

November 30, 2021

Last Update Submit

June 25, 2022

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Time to first requested rescue analgesia(Minutes)

    Time to first requested rescue analgesia(Minutes)

    24 hours postoperatively

Study Arms (3)

Group Erector Spinae Plane Block (ESPB)

ACTIVE COMPARATOR
Other: Group Erector Spinae Plane Block (ESPB)

Group Quadratus Lumborum Block (QLB)

ACTIVE COMPARATOR
Other: Group Quadratus Lumborum Block (QLB)

Group (C) (Control group)

OTHER
Other: Group (C) (Control group)

Interventions

Group Erector Spinae Plane Block (ESPB)OTHER

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 "

Group Erector Spinae Plane Block (ESPB)
Group Quadratus Lumborum Block (QLB)OTHER

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 "

Group Quadratus Lumborum Block (QLB)
Group (C) (Control group)OTHER

Where patients will be operated under general anesthesia.

Group (C) (Control group)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
  • BMI \> 35 kg/ m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population GroupsControl Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 2, 2021

Study Start

December 15, 2021

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

EG(1)