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OpenTrials
Completed

NCT Number: NCT06685081

Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

Chronic low back pain (CLBP) is a prevalent condition causing significant pain, disability, and reduced quality of life. While various treatments like exercise, NSAIDs, and spinal manipulation are recommended, their effectiveness is limited. Epidural steroid injections can provide short-term relief but may not be cost-effective and have associated risks.

Dexmedetomidine (DXM) is a selective α2-adrenergic agonist with analgesic properties. It has been used as an adjuvant to anesthetics and analgesics to enhance pain relief and reduce opioid consumption. Using DXM in conjunction with local anesthetics for regional blocks has shown promising results in improving analgesia and functional outcomes.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Shibīn al Kawm, El Menoufia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of daily activities;
  • Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks with manifest affection of quality of walking and life;
  • Patients who had Chronic Lower Back pain defined as persistent pain for more than 6 weeks maintained on systemic analgesics;
  • Patients who were free of exclusion criteria were enrolled in the study.

Exclusion criteria

  • The presence of osteolytic vertebral lesions;
  • The Presence of previous surgical intervention;
  • The presence of allergy to the studied drugs;
  • Patients of ASA grade >II.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine was injected in dose of 0.25 µg/kg

lidocaine and triamcinolone

Drug

2 ml of 1.5% lidocaine and 2 ml of triamcinolone was mixed and provided to all patients as epidural injection

Primary outcomes

  1. Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.

    Time frame: 3 months

    Value of Dexmedetomidine injection in Pain Reduction post operatively manifested by recurrence of pain.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Optimal-dose of Dexmedetomidine as Adjuvant to Epidural Local Anesthetic/Steroid Injectate to Improve Pain and Quality of Waking in Patients With Chronic Low Back Pain: A Randomized Case-control Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Nov 12, 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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