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NCT Number: 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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Thoracolumbar Interfascial Plane Block using Bupivacaine and dexmedetomidine

Primary outcomes

  1. total opioid consumption

    Time frame: 24 hours

    To assess the total perioperative (intraoperative and 24 h postoperative) opioid consumption in the first 24 h.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohand Mohamed Fathy Salem

CONTACT

[email protected]

+2 01121482878

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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