Dexmedetomidine Infusion Impact on Chronic Pain Patients

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Drug: normal saline; Drug: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)

• Registration Number: NCT06402019
• Lead Sponsor: Benha University

Brief Summary

Chronic pain (CP) was defined as pain experienced daily or on most days and induced restriction of at least one activity. CP is one of the commonest complaints confronted in outpatient clinics and constitutes a challenge for all medical provisions. CP is a multifaceted condition; postoperative CP is frequently encountered in clinical practice and may be of debilitating severity leading to worse quality of life (QOL) especially CP with a neuropathic component as post-mastectomy pain syndrome and post-amputation pain and chronic post-sternotomy pain that seriously impacts patients' QOL and affects patient recovery till 12 months after cardiac surgery. Chronic musculoskeletal pain as defined by the International Pain Association is the persistent or recurrent pain involving spine, bones, joints, and/or musculo-soft tissue.

Chronic pain was considered as a long-lasting stressor that might induce disordered mood varying between depression and anxiety with consequent challenge of this combination on treatment outcomes and consumption of health resources. This necessitated psychological screening of CP patient to identify and manage patients with disordered mood to improve CP treatment outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-09-22
• Study Completion: 2023-12-01
• Study First Submitted: 2024-04-13
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with multiple-level spinal canal stenosis who refused surgical management.

Exclusion Criteria

• Patients with other causes for CP;
• maintained on opioid analgesia;
• had cardiac lesions;
• maintained on antihypertensive therapy;
• hepatic impairment;
• Patients can't attend the clinic to complete the course of Dexmedetomidine infusion sessions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	normal saline	-
Intervention Group	Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)	-

Primary Outcome Measures

Name	Time	Method
The extent of reduction of consumed analgesics	6 months	Necessity of Dexmedetomidine infusion as management procedure to the chronic pain patients

Trial Locations

Locations (1)

Benha university; 🇪🇬 Banhā, Qalyoubia, Egypt