Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

NCT06685081 | Completed

• 1 other identifier: 7-2024ANST5
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

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.

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

  3 months

Study Arms (5)

Group I

ACTIVE COMPARATOR

Drug: lidocaine and triamcinolone

Group II

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

Group III

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

Group IV

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

Group V

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: lidocaine and triamcinolone

Interventions

Dexmedetomidine DRUG

Dexmedetomidine was injected in dose of 0.25 µg/kg

Group II

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

Group I; Group II; Group III; Group IV; Group V

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, El Menoufia, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Lidocaine; Triamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: July 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

EG (1)