Comparing the Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries

November 13, 2024 updated by: Mohand Mohamed Fathy Salem, Assiut University
Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain control after spinal surgeries has been a topic of interest for researchers in the past decade. Indeed, poor pain control can not only impact patient satisfaction but also delay rehabilitation and increase healthcare costs.

The thoracolumbar interfascial plane (TLIP) block was defined by Hand et al. for reducing pain following spinal surgery. In this block, the anesthetic drug is administered between the multifidus and longissimus muscles to target the dorsal ramus of the thoracolumbar nerves. The TLIP block was later modified by Ahiskalioglu et al., with the involvement of the administration of a local anesthetic between the longissimus and iliocostalis, which was observed to demonstrate a dermatomal dispersion similar to that by the TLIP block.

Dexmedetomidine is highly specific and highly selective a2-adrenoceptive agonist and it's action is selective to the CNS without the unwanted effect on the CVS that would result from a activation . It has been found that, in many experimental and clinical regional block practices, the addition of dexmedetomidine to the local anesthetic reduces tissue and nerve damage, increases duration of sensory and motor block, and reduces postoperative pain.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

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

No

Description

Inclusion Criteria:

  • • Age >18 years old

    • Both sex
    • Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

Exclusion Criteria:

  • • Patient refusal.

    • coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
    • skin lesions or infection at site of proposed needle.
    • known allergy to local anesthetics or dexmedetomidine.
    • patients suffering from mental disease as cannot Assess the Visual Analogue Scale (VAS) that measures pain intensity as, mental retardation & psychosis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
Classical Thoracolumbar Interfascial Plane Block
Drug: Dexmedetomidine
Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine
Experimental: group 2
Modified Thoracolumbar Interfascial Plane Block
Drug: Dexmedetomidine
Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total opioid consumption
Time Frame: 24 hours
To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative VAS score
Time Frame: 24 hours
Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) VAS scale. VAS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexmedetomidine TLIP lumbar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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