Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

June 17, 2023 updated by: Hassan Mokhtar Elshorbagy Hetta, Minia University

Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study

To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Minia
      • Minya, Minia, Egypt, 61511
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age18-60.
  2. Both genders.
  3. abdominal surgery.
  4. ASA I-III.

Exclusion Criteria:

  1. Drug allergy.
  2. Morbid obesity (BMI >40 kg/m2).
  3. Psychiatric disorder.
  4. Opiod dependence.
  5. patient refuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single ESPB
single injection at level T8
Procedure: single level
injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)
Experimental: dual ESB
dual injection at level T7 and T9
Procedure: dual level
injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first analgesic request
Time Frame: 24 hours
time to request fentanyl
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting visual analogue pain scale
Time Frame: 24 hours
pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain
24 hours
dynamic visual analogue pain scale
Time Frame: 24 hours
pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain
24 hours
analgesic consumption
Time Frame: 24 hours
total fentanyl required first day postoperative
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: hassan m. hetta, lecturer, minia university/ faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 474:10/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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