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Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

Primary Purpose

Post Operative Pain, Regional Block

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

single level

dual level

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring ESPB, pain, regional block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

single ESPB

dual ESB

Arm Description

single injection at level T8

dual injection at level T7 and T9

Outcomes

Primary Outcome Measures

first analgesic request

time to request fentanyl

Secondary Outcome Measures

resting visual analogue pain scale

pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain

dynamic visual analogue pain scale

pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain

analgesic consumption

total fentanyl required first day postoperative

Full Information

NCT ID

NCT05633329

First Posted

November 4, 2022

Last Updated

June 17, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05633329

Brief Title

Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 7, 2022 (Actual)

Primary Completion Date

May 1, 2023 (Actual)

Study Completion Date

June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain, Regional Block

Keywords

ESPB, pain, regional block

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single ESPB

Arm Type

Experimental

Arm Description

single injection at level T8

Arm Title

dual ESB

Arm Type

Experimental

Arm Description

dual injection at level T7 and T9

Intervention Type

Procedure

Intervention Name(s)

single level

Intervention Description

injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)

Intervention Type

Procedure

Intervention Name(s)

dual level

Intervention Description

injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)

Primary Outcome Measure Information:

Title

first analgesic request

Description

time to request fentanyl

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

resting visual analogue pain scale

Description

pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain

Time Frame

24 hours

Title

dynamic visual analogue pain scale

Description

pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain

Time Frame

24 hours

Title

analgesic consumption

Description

total fentanyl required first day postoperative

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hassan m. hetta, lecturer

Organizational Affiliation

minia university/ faculty of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minia University

City

Minya

State/Province

Minia

ZIP/Postal Code

61511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

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