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

NCT04757480 | Unknown

• 1 other identifier: 33444/10/19
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Lumbar Laminectomy; Thoracolumbar Interfascial Plane Block; Erector Spinae Plane Block; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Degree of pain by visual Analog Scale (VAS) score at movement

  First 24 hours postoperative

• Total rescue analgesics consumption

  First 24 hours postoperative

• The time to first analgesic

  First 24 hours postoperative

• 24-h morphine consumption

  First 24 hours postoperative

• Side effects associated with morphine

  First 24 hours postoperative

Study Arms (2)

Thoracolumbar Interfascial Plane Block (TLIP)

EXPERIMENTAL

Procedure: Thoracolumbar Interfascial Plane Block (TLIP)

Bilateral Erector Spinae plane Block (ESB)

EXPERIMENTAL

Procedure: Bilateral Erector Spinae plane Block (ESB)

Interventions

Thoracolumbar Interfascial Plane Block (TLIP) PROCEDURE

(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.

Thoracolumbar Interfascial Plane Block (TLIP)

Bilateral Erector Spinae plane Block (ESB) PROCEDURE

Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).

Bilateral Erector Spinae plane Block (ESB)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Body mass index \>32
• History of relevant allergy to any of the drugs used in the procedure
• Previous lumbar spine surgery or back surgery with planed spinal fixation

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 10, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)