Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

• Registration Number: NCT06685081
• Lead Sponsor: Menoufia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-10-15
• Status Verified: 2024-11
• Study Completion: 2024-11-01
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group V	lidocaine and triamcinolone	-
Group III	Dexmedetomidine	-
Group III	lidocaine and triamcinolone	-
Group IV	Dexmedetomidine	-
Group IV	lidocaine and triamcinolone	-
Group V	Dexmedetomidine	-
Group I	lidocaine and triamcinolone	-
Group II	Dexmedetomidine	-
Group II	lidocaine and triamcinolone	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) in post-Operative Follow up for Spine Surgery.	3 months	Value of Dexmedetomidine injection in Pain Reduction post operatively manifested by recurrence of pain.

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, El Menoufia, Egypt