mTLIP vs. ITP Blocks in Lumbar Disc Surgery

NCT06391541 | Active Not Recruiting

• 1 other identifier: 2024/06-18
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia.

Conditions

Lumbar Disc Herniation; Pain, Postoperative; Regional Aneshesia

Keywords

postoperative pain; opioid consumption; Pain management; nerve blocks; QoR-15

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  total amount of opioids consumed in 24 hours postoperatively

  up to 24 hours after surgery

Secondary Outcomes (3)

• pain scores

  up to 24 hours after surgery

• incidence of nausea and vomiting

  up to 24 hours after surgery

• Quality of Recovery-15 scale

  24 hours after surgery

Study Arms (3)

Group Control

NO INTERVENTION

Group mTLIP

ACTIVE COMPARATOR

Procedure: modified thoracolumbar interfacial plan block (mTLIP)

Group ITP

ACTIVE COMPARATOR

Procedure: Intertransverse process block (ITP)

Interventions

modified thoracolumbar interfacial plan block (mTLIP) PROCEDURE

Injecting local anesthetic at L3 vertebral level between the longisimus and iliocostalis muscles within the erector spinae muscles.

Group mTLIP

Intertransverse process block (ITP) PROCEDURE

injection of local anesthetic on the superior costotransverse ligament between the transverse process and the pleura.

Group ITP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA I-II-III risk group
• Patients whose consent was obtained with an informed consent form
• Patients who will undergo lumbar disc herniation surgery

You may not qualify if:

• Patients who refused to participate in the study
• Allergic to local anesthetics
• Patients with coagulopathy
• Infection at the site of intervention
• Patients under 18 years of age
• Patients with ASA score IV and above
• Chronic pain disorders
• Those with neurological or neuromuscular disease
• Patients with psychiatric problems
• Patients with a history of opioid use
• Chronic use of NSAIDs
• Those contraindicated for regional anesthesia
• Patients with a history of opioid use
• Chronic analgesic use

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University medicine faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)