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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lumbar Disc Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

An independent anesthesiologist randomly using computer-generated random numbers divided the patients into 2 groups :(Group 1 and Group 2). Each group will include 15 patients. We discreetly placed the randomization results in envelopes until the end of the study. The researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation

Study Groups

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group 1

Classical Thoracolumbar Interfascial Plane Block

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

group 2

Modified Thoracolumbar Interfascial Plane Block

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

Interventions

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Dexmedetomidine

Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No