Dexmedetomidine Infusion Impact on Chronic Pain Patients

NCT ID: NCT06402019

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-12-01

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)

Intervention Type: DRUG

Group went under multiple sessions of Dexmedetomidine infusion for 10 sessions; The infusion was provided under non-invasive monitoring for heart rate (HR) and mean arterial pressure (MAP). The infusion rate was adjusted to maintain HR in range of 60-80 beats/min and MAP in range of 65-75 mmHg.

Control Group

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

Group went under multiple sessions of normal saline injection.

Interventions

Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)

Group went under multiple sessions of Dexmedetomidine infusion for 10 sessions; The infusion was provided under non-invasive monitoring for heart rate (HR) and mean arterial pressure (MAP). The infusion rate was adjusted to maintain HR in range of 60-80 beats/min and MAP in range of 65-75 mmHg.

Intervention Type: DRUG

normal saline

Group went under multiple sessions of normal saline injection.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Salsabil Sayed Abdelkader

Clinical lecturer at Department of Anesthesia, Pain & ICU, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha university

Banhā, Qalyoubia, Egypt

Countries

Egypt

Other Identifiers

RC.9.3.2024

Identifier Type: -

Identifier Source: org_study_id