Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05705739
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.8
• Patients Per Site Per Month: 8.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain; Analgesia	Procedure: retrolaminar block; Procedure: ESPB	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Feb 5, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

1. Visual analogue pain scale [24 hour]

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

Secondary Outcome Measures

1. Time of first post operative analgesic request. [24 hour]

   time to demand rescue analgesia

2. Total analgesic consumption [24 hour]

   total fentanyl consumption during the first day postoperative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Minia University

Investigators

None specified.

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: NCT05705739
• Other Study ID Numbers: 544/2022
• First Posted: Jan 31, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Feb 6, 2023