Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05633329

Collaborator

(none)

Enrollment

Location

Arms

4.2

Anticipated Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Regional Block	Procedure: single level Procedure: dual level	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 7, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

first analgesic request [24 hours]
time to request fentanyl

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age18-60.
Both genders.
abdominal surgery.
ASA I-III.

Exclusion Criteria:

Drug allergy.
Morbid obesity (BMI >40 kg/m2).
Psychiatric disorder.
Opiod dependence.
patient refuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University	Minya	Minia	Egypt	61511

Sponsors and Collaborators

Minia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hassan Mokhtar Elshorbagy Hetta, lecturer of anesthesia and ICU, Minia University

ClinicalTrials.gov Identifier:

NCT05633329

Other Study ID Numbers:

474:10/2022

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hassan Mokhtar Elshorbagy Hetta, lecturer of anesthesia and ICU, Minia University

ESPB

pain

regional block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Dec 9, 2022