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Not yet recruiting NCT06690021

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

Phase IV Interventional Lumbar Disc Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine.
Who it may be relevant to
Registry conditions: Lumbar Disc Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Drug Dexmedetomidine
    Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

Primary outcome measures

  • total opioid consumption [Time frame: 24 hours]
Secondary outcome measures (1)
  • post operative VAS score [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18. PMID 30429737
  • Sarvesh B, Shivaramu BT, Sharma K, Agarwal A. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018 Oct-Dec;12(4):809-813. doi: 10.4103/aer.AER_141_18. PMID 30662112
  • Nasr DA, Abdelhamid HM. The efficacy of caudal dexmedetomidine on stress response and postoperative pain in pediatric cardiac surgery. Ann Card Anaesth. 2013 Apr-Jun;16(2):109-14. doi: 10.4103/0971-9784.109744. PMID 23545865
  • Tantri AR, Sukmono RB, Lumban Tobing SDA, Natali C. Comparing the Effect of Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain and IL-6 Level in Posterior Lumbar Decompression and Stabilization Surgery. Anesth Pain Med. 2022 Apr 12;12(2):e122174. doi: 10.5812/aapm-122174. eCollection 2022 Apr. PMID 36061531
  • Mondal S, Pandey RK, Kumar M, Sharma A, Darlong V, Punj J. Analgesic efficacy of classical thoracolumbar interfascial plane block versus modified thoracolumbar interfascial plane block in patients undergoing lumbar disc surgeries: A comparative, randomised controlled trial. Indian J Anaesth. 2024 Apr;68(4):366-373. doi: 10.4103/ija.ija_1153_23. Epub 2024 Mar 13. PMID 38586260
  • Khan MA, Gupta M, Sharma S, Kasaudhan S. A comparative study of ultrasound assisted versus landmark technique for combined spinal-epidural anaesthesia in patients undergoing lower limb orthopaedic surgery. Indian J Anaesth. 2022 Apr;66(4):272-277. doi: 10.4103/ija.ija_775_21. Epub 2022 Apr 20. PMID 35663223

Identifiers

NCT: NCT06690021 · Dexmedetomidine TLIP lumbar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗