Regional Blocks for Lumbar Disc Surgery Analgesia

NCT06933641 | Completed

• 1 other identifier: 2024-07/06
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The goal of this prospective randomized controlled experiment was comparing the analgesic efficacy, opioid needs, and adverse effect profiles of Paravertebral Block (PVB), Thoracolumbar Interfascial Plane Block (TLIP), and Retrolaminar Block (RLB) in patients undergoing lumbar disc herniation surgery. Methods 180 adults (ASA I-III) undergoing elective lumbar disc herniation surgery made up this single-center study. Among the exclusion criteria were coagulation problems, injection site infection, allergy to local anesthetics, and incapacity to provide informed consent. Patients were randomly assigned into four groups: Control (systemic analgesia only), PVB, TLIP, and RLB (45 patients per group). An expert anesthesiologist supervised the ultrasonography during each block. The Visual Analog Scale (VAS) was used to measure postoperative pain at 0, 1, 2, 6, 12, and 24 hours after surgery. This was the primary outcome. Motor block incidence, rescue morphine consumption, and Quality of Recovery-40 (QoR-40) scores at 24 hours were secondary objectives. Unfavorable incidents were noted. ANOVA and Kruskal-Wallis tests (p\<0.05) were used to examine the data.

Conditions

Analgesia

Keywords

Lumbar Vertebrae; Postoperative Pain; Nerve Block; Interfascial Plane Blocks; Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The pain is scaled with Visual Analogue Scale score in 4 groups

  0 hour, 1 hour, 2 hour, 6 hour, 12 hour, 24 hour after surgery

Study Arms (4)

Control Group

NO INTERVENTION

All patients received routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.

Paravertebral Block Group

ACTIVE COMPARATOR

All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.

Procedure: Regional Analgesia

Thoracolumbar Interfascial Plane Block Group

EXPERIMENTAL

All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.

Procedure: Regional Analgesia

Retrolaminar Block Group

EXPERIMENTAL

All patients received regional analgesia and routine intravenous analgesia with 1 g paracetamol and 1 mg/kg tramadol hydrochloride every 12 hours during postoperative ward follow-ups.

Procedure: Regional Analgesia

Interventions

Regional Analgesia PROCEDURE

20 cc of local anesthetic solution, comprising 10 cc of 0.5% bupivacaine and 10 cc of 0.9% NaCl bilaterally, was injected into each side once

Paravertebral Block Group; Retrolaminar Block Group; Thoracolumbar Interfascial Plane Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and 65 who were having elective lumbar disc herniation surgery and had ASA I-III ratings made up the study

You may not qualify if:

• The study excluded patients having a history of opioid dependency, coagulation issues, difficult behavior, pharmaceutical allergies, prior spinal surgery, or unwillingness to participate in the experiment

Sponsors & Collaborators

• Erzincan University: lead

Study Sites (1)

Erzincan University

Erzincan, Merkez, 24000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Hakan Gökalp Taş

  Erzincan Binali Yildirim Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 18, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

TU (1)