Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy

• Sponsor: Tanta University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04757480
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.3
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

The aim of this prospective randomized trial is to compare the efficacy ultrasound guided thoracolumbar interfascial plane block versus bilateral ultrasound guided erector spinae plane block for post-operative pain management after lumbar laminectomy

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Lumbar Laminectomy; Thoracolumbar Interfascial Plane Block; Erector Spinae Plane Block; Ultrasound	Procedure: Thoracolumbar Interfascial Plane Block (TLIP); Procedure: Bilateral Erector Spinae plane Block (ESB)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Oct 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thoracolumbar Interfascial Plane Block (TLIP)	Procedure: Thoracolumbar Interfascial Plane Block (TLIP); (20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.
Experimental: Bilateral Erector Spinae plane Block (ESB)	Procedure: Bilateral Erector Spinae plane Block (ESB); Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).

Outcome Measures

Primary Outcome Measures

1. Degree of pain by visual Analog Scale (VAS) score at rest [First 24 hours postoperative]

   Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h. VAS score from 0 to 10 (0: No pain, 10: The worst pain)

Secondary Outcome Measures

1. Degree of pain by visual Analog Scale (VAS) score at movement [First 24 hours postoperative]

   Pain scores will be observed and recorded using the Visual Analog Scale (VAS) both at rest and during movement. The scores will be recorded in the ward at 2, 4, 8, 12, and 24 h VAS score from 0 to 10 (0: No pain, 10: The worst pain)

2. Total rescue analgesics consumption [First 24 hours postoperative]

3. The time to first analgesic [First 24 hours postoperative]

4. 24-h morphine consumption [First 24 hours postoperative]

5. Side effects associated with morphine [First 24 hours postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.

Exclusion Criteria:

1. Body mass index >32

2. History of relevant allergy to any of the drugs used in the procedure

3. Previous lumbar spine surgery or back surgery with planed spinal fixation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta	ElGharbiaa	Egypt	31511

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aliaa Mohammad Abdel Reeheem Abdel kader, Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT04757480
• Other Study ID Numbers: 33444/10/19
• First Posted: Feb 17, 2021
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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 17, 2021