Erector Spinae Plane Block Versus Quadratus Lumborum Bloc... | NCT05541588

Studies
Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy

NCT05541588

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 29, 2024Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

peripheral nerve block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Feb 10, 2023Actual

First Submitted Date

Sep 13, 2022

First Submission Date that Met QC Criteria

Sep 13, 2022

First Posted Date

Sep 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2024

Last Update Posted Date

Jul 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Khaled Abdou, clinical assistant professor -Ain Shams University, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESPB	Active Comparator	Erector Spinae Plane Block group	Procedure: peripheral nerve block
QLB	Active Comparator	Quadratus Lumborum Block group	Procedure: peripheral nerve block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
peripheral nerve block	Procedure	ultrasound guided nerve block	ESPB QLB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative pain	Post-operative pain severity assessed by visual analog scale (VAS) (range from 0-10., 0 no pain, 10 worst pain ).	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Cumulative post-operative opioid consumption	opioid consumption	24 hours
The onset of 1st analgesic request	time needed for 1st request of rescue analgesia

Other Outcomes

Measure	Description	Time Frame
Incidence of complications	postoperative nausea and vomiting(PONV), hematoma, local anaesthetic toxicity (LAT)	24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
scheduled for abdominal hysterectomy surgery.

Exclusion Criteria:

History of allergy to the medications used in the study.
Contraindication to regional anesthesia as coagulopathy, local infection.
Severe hepatic impairment (child C).
Sever Renal dysfunction (creatinine clearance < 30).
Psychiatric or mental disorder affecting patient ability to interpret VAS score.
Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
ASA IV.
Patient refusal.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

females

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided