NCT06564610

Brief Summary

The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

January 13, 2025

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 16, 2024

Last Update Submit

January 10, 2025

Conditions

Pain, PostoperativeObesityAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Numerical rating scale

    This is a scale for pain assessment which ranges between 0 and 10 with the highest level of pain having score 10 and lowest level of pain having score 0

    24 hours after surgery

Secondary Outcomes (5)

  • Consumption of analgesia

    24 hours after surgery

  • Heart rate

    24 hours after surgery

  • Systolic blood pressure

    24 hours after surgery

  • Vomiting

    24 hours

  • Diastolic blood pressure

    24 hours

Study Arms (2)

Transversus abdominis block

EXPERIMENTAL

Patients in this group will receive Transversus Abdominis block guided by the laparoscope at the beginning of surgery.

Procedure: Transversus abdominis blockProcedure: Bariatric surgeryDevice: Endotracheal intubationDrug: Propofol

Erector spinae block

ACTIVE COMPARATOR

Patients in this group will receive Erector Spinae block guided by the ultrasound after induction of anesthesia.

Procedure: Erector spinae blockProcedure: Bariatric surgeryDevice: Endotracheal intubationDrug: Propofol

Interventions

Transversus abdominis blockPROCEDURE

The block will be performed by the surgeon by injecting local anesthetic at the beginning of surgery under the guidance of the laparoscope.

Transversus abdominis block
Erector spinae blockPROCEDURE

The block will be performed by the anesthetist by injecting local anesthetic after induction of anesthesia under the guidance of the ultrasound.

Erector spinae block
Bariatric surgeryPROCEDURE

Laparoscopic bariatric procedure will be performed

Erector spinae blockTransversus abdominis block
Endotracheal intubationDEVICE

An endotracheal tube will be inserted as a part of general anesthesia to all patients

Erector spinae blockTransversus abdominis block
PropofolDRUG

The patients will receive propofol for induction of anesthesia

Erector spinae blockTransversus abdominis block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.

You may not qualify if:

  • Allergy to local anaesthetic.
  • Bleeding disorders.
  • Obstructive sleep apnea.
  • inability to understand the numerical rating scale for pain assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Cairo University.

Cairo, Cairo Governorate, 11432, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativeObesityAgnosia

Interventions

Bariatric SurgeryIntubation, IntratrachealPropofol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeAirway ManagementIntubationInvestigative TechniquesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ahmed Hasanin, Professor

    Professor of anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 21, 2024

Study Start

August 25, 2024

Primary Completion

January 5, 2025

Study Completion

January 9, 2025

Last Updated

January 13, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)