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

Postoperative Pain Clinical Trial

Official title:

Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04757480
• Other study ID #: 33444/10/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 10, 2021

Study information

• Verified date: February 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 10, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Lumbar Laminectomy
• Pain, Postoperative
• Postoperative Pain
• Thoracolumbar Interfascial Plane Block
• Ultrasound

Intervention

Procedure:
• Thoracolumbar Interfascial Plane Block (TLIP)
(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.
• 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).

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of pain by visual Analog Scale (VAS) score at rest	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)	First 24 hours postoperative
Secondary	Degree of pain by visual Analog Scale (VAS) score at movement	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)	First 24 hours postoperative
Secondary	Total rescue analgesics consumption		First 24 hours postoperative
Secondary	The time to first analgesic		First 24 hours postoperative
Secondary	24-h morphine consumption		First 24 hours postoperative
Secondary	Side effects associated with morphine		First 24 hours postoperative