mTLIP vs. ITP Blocks in Lumbar Disc Surgery

April 29, 2024 updated by: Çağdaş Baytar, Zonguldak Bulent Ecevit University

Comparison of the Effects of Modified Thoracolumbar Interfacial Plan Block (mTLIP) and Intertransverse Process Block in Lumbar Disc Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-75 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group Control
Active Comparator: Group mTLIP
Procedure: modified thoracolumbar interfacial plan block (mTLIP)
Injecting local anesthetic at L3 vertebral level between the longisimus and iliocostalis muscles within the erector spinae muscles.
Active Comparator: Group ITP
Procedure: Intertransverse process block (ITP)
injection of local anesthetic on the superior costotransverse ligament between the transverse process and the pleura.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: up to 24 hours after surgery
total amount of opioids consumed in 24 hours postoperatively
up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: up to 24 hours after surgery
Patients will be evaluated at regular intervals after surgery and their pain will be measured using a numerical rating scale.
up to 24 hours after surgery
incidence of nausea and vomiting
Time Frame: up to 24 hours after surgery
nausea and vomiting of postoperative patients will be evaluated
up to 24 hours after surgery
Quality of Recovery-15 scale
Time Frame: 24 hours after surgery
The quality of recovery of patients will be assessed with the quality of recovery 15 questionnaire.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/06-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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