NCT05533710

Brief Summary

This study aims to compare the ultrasound-guided bilateral erector spinae block versus the ultrasound-guided bilateral transversus abdominis plane block on postoperative analgesia after total abdominal hysterectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 28, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

September 3, 2022

Last Update Submit

September 7, 2022

Conditions

Uterine Diseases

Keywords

ESPB, TAP

Outcome Measures

Primary Outcomes (3)

  • Total morphine consumption

    Compare postoperative pain intensity using the total amount of morphine consumption in the first 24 hours after the operation, and the time for first call rescue analgesia

    24 hours postoperative

  • Visual Analog Scale Score

    Compare postoperative pain intensity using VAS score in the first 24 hours after the operation.The VAS score is a 10-cm line labeled with "worst pain imaginable" on the right border, and "no pain" on the left border (ranging from 0 by indicating no pain to 10 indicating extreme pain).

    24 hours postoperative

  • The time for first call rescue analgesia

    the time for first call rescue analgesia

    24 hours postoperative

Secondary Outcomes (2)

  • Patient satisfaction

    24 hours postoperative

  • Recognize the adverse effects

    24 hours postoperative

Study Arms (2)

Group A : erector spinae block.

EXPERIMENTAL

patients will receive bilateral ultrasound guided erector spinae block.

Procedure: erector spinae plane block

Group B : transversus abdominis plane block.

EXPERIMENTAL

patients will receive bilateral ultrasound guided transversus abdominis plane block.

Procedure: transversus abdominis plane block

Interventions

erector spinae plane blockPROCEDURE

Patients will receive ESB. In the lateral decubitus, after skin sterilization, ESP block will be performed at the level of T9

Group A : erector spinae block.
transversus abdominis plane blockPROCEDURE

patients will receive TAP block in supine position after skin sterilization, TAP block will be performed between internal oblique and transversus abdominis muscles

Group B : transversus abdominis plane block.

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients American Society of Anesthesiologists physical status (ASA) I and II.
  • Female sex.
  • Age between 40 to 60 years old.
  • Scheduled for elective total abdominal hysterectomy surgeries.

You may not qualify if:

  • Patient's refusal.
  • Patients who received long-acting opioids preoperatively.
  • Patients with bleeding disorders and coagulopathy.
  • Infection at the injection site.
  • Allergy to local anesthetics.
  • Patients with significant cognitive dysfunction.
  • Patients with diabetic neuropathy.
  • Patients with uncontrolled hypertension or diabetes.
  • Patients with advanced cardiac, respiratory, hepatic or renal disease.
  • Patients with viral hepatitis or HIV.
  • Surgeries which have been complicated or prolonged (more than 150 mins).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • ossama mansour, professor

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

israa ihab, MSc

CONTACT

01005461696israa_ihab@med.asu.edu.eg

Study Design

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

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 9, 2022

Study Start

August 28, 2021

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)