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Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

Primary Purpose

Post Operative Pain, Analgesia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

retrolaminar block

ESPB

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age18-60. Both genders. hepatobiliary surgery. ASA I-III. Exclusion Criteria: Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opiod dependence.

Sites / Locations

Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Retrolaminar plane block

ESPB

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue pain scale

score from 0-10 (0 mean no pain and 10 the worst pain )

Secondary Outcome Measures

Time of first post operative analgesic request.

time to demand rescue analgesia

Total analgesic consumption

total fentanyl consumption during the first day postoperative

Full Information

NCT ID

NCT05705739

First Posted

January 20, 2023

Last Updated

October 12, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05705739

Brief Title

Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

Official Title

Comparison Between the Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block for Postoperative Pain in Patients Undergoing Hepatobiliary Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

February 10, 2023 (Actual)

Primary Completion Date

July 1, 2023 (Actual)

Study Completion Date

August 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

5. Study Description

Brief Summary

Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space. the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.

6. Conditions and Keywords

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

Post Operative Pain, Analgesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Retrolaminar plane block

Arm Type

Experimental

Arm Title

ESPB

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

retrolaminar block

Intervention Description

curved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina

Intervention Type

Procedure

Intervention Name(s)

ESPB

Intervention Description

curved probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle.

Primary Outcome Measure Information:

Title

Visual analogue pain scale

Description

score from 0-10 (0 mean no pain and 10 the worst pain )

Time Frame

24 hour

Secondary Outcome Measure Information:

Title

Time of first post operative analgesic request.

Description

time to demand rescue analgesia

Time Frame

24 hour

Title

Total analgesic consumption

Description

total fentanyl consumption during the first day postoperative

Time Frame

24 hour

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. hepatobiliary surgery. ASA I-III. Exclusion Criteria: Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opiod dependence.

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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Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

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