Clonidine for postoperative pain management in patients undergoing spine surgery

Phase 1

Active, not recruiting

Conditions: Degenerative spine diseases
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2023-505969-80-00

Lead Sponsor: Aarhus Universitetshospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients scheduled for degenerative spine surgery at Aarhus University Hospital will be included in the study.

Exclusion Criteria

Age < 18 years, Pregnancy and/or lactation, Planned treatment with epidural analgesia, methadone, or infusion of ketamine in the perioperative period, American Society of Anesthesiologists (ASA) physical status IV or V, Allergy to clonidine, Inability to provide informed consent, Known severe renal insufficiency (eGFR < 30), Known severe bradyarrhythmia, Known severe ischemic heart disease, Known severe congestive heart failure (Ejection Fraction < 30%), Known severe disseminated cancer disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU;Main Objective: To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption;Secondary Objective: To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption, pain intensity and opioid-related side effects

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Postoperative opioid consumption within the first 6 hours after arrival at the PACU;Secondary end point(s):Daily opioid consumption after 1 month;Secondary end point(s):Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10);Secondary end point(s):Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsey Sedation Score 1-6);Secondary end point(s):Nausea and/or vomiting at 0, 60, and 120 minutes after arrival at the PACU (yes/no);Secondary end point(s):Time for discharge from the PACU;Secondary end point(s):Length of hospital stay