NCT05541588

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

September 13, 2022

Last Update Submit

July 26, 2024

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Cumulative post-operative opioid consumption

    24 hours

  • The onset of 1st analgesic request

    24 hours

Other Outcomes (1)

  • Incidence of complications

    24 hours

Study Arms (2)

ESPB

ACTIVE COMPARATOR

Erector Spinae Plane Block group

Procedure: peripheral nerve block

QLB

ACTIVE COMPARATOR

Quadratus Lumborum Block group

Procedure: peripheral nerve block

Interventions

peripheral nerve blockPROCEDURE

ultrasound guided nerve block

ESPBQLB

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams univerisity

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor -Ain Shams University

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

July 7, 2022

Primary Completion

January 20, 2023

Study Completion

February 10, 2023

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

EG(1)