Dexmedetomidine for Improved Pain Relief and Recovery in Spine Surgery

NCT ID: NCT06685081

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-11-01

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group I

Group Type ACTIVE_COMPARATOR

lidocaine and triamcinolone

Intervention Type DRUG

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

Group II

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was injected in dose of 0.25 µg/kg

lidocaine and triamcinolone

Intervention Type DRUG

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

Group III

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was injected in dose of 0.5 µg/kg

lidocaine and triamcinolone

Intervention Type DRUG

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

Group IV

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was injected in dose of 0.75 µg/kg

lidocaine and triamcinolone

Intervention Type DRUG

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

Group V

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was injected in dose of 1 µg/kg

lidocaine and triamcinolone

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

Dexmedetomidine was injected in dose of 0.25 µg/kg

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine was injected in dose of 0.5 µg/kg

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine was injected in dose of 0.75 µg/kg

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine was injected in dose of 1 µg/kg

Intervention Type DRUG

lidocaine and triamcinolone

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

Intervention Type DRUG

Eligibility Criteria

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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;

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Helwa

Lecturer of Anesthesia, Pain & ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University

Shibīn al Kawm, El Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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7-2024ANST5

Identifier Type: -

Identifier Source: org_study_id

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