Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Post Operative Pain
• Intervention / Treatment: Procedure: retrolaminar block; Procedure: ESPB

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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. hepatobiliary surgery.
4. ASA I-III.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESPB	Procedure: ESPB; 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.
Experimental: Retrolaminar plane block	Procedure: retrolaminar block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain scale	score from 0-10 (0 mean no pain and 10 the worst pain )	24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first post operative analgesic request.	time to demand rescue analgesia	24 hour
Total analgesic consumption	total fentanyl consumption during the first day postoperative	24 hour

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 544/2022

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