Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

Menoufia University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06685081

7-2024ANST5

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 5 patient groups

Group I

Active Comparator group

Treatment:

Drug: lidocaine and triamcinolone

Group II

Active Comparator group

Treatment:

Drug: lidocaine and triamcinolone

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Group III

Active Comparator group

Treatment:

Drug: lidocaine and triamcinolone

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Group IV

Active Comparator group

Treatment:

Drug: lidocaine and triamcinolone

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Group V

Active Comparator group

Treatment:

Drug: lidocaine and triamcinolone

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine

Drug: Dexmedetomidine