Reduction Of Chronic Post-surgical Pain with Ketamine - ROCKet Trial

Phase 3

Recruiting

• Conditions: Chronic post-surgical pain; Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12617001619336
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4884

Inclusion Criteria

Patients with ASA 1-3 undergoing elective or expedited surgery and anaesthesia for abdominal surgery involving an expected skin incision at least 8cm in length and including open herniorraphy; non-cardiac thoracic surgery, including mastectomy and breast reconstruction surgery, and including all video-assisted thoracoscopic surgery; hip, knee and shoulder joint arthroplasty and spinal surgery involving an expected skin incision at least 8cm; plan for postoperative opioid analgesia; planned hospital stay of at least one night post-operatively; expected to be alive at 12 months post index surgery.

Exclusion Criteria

Patients unable to provide written informed consent
Patients who are pregnant or lactating
Body mass index (BMI) over 40 kg/m2 and weight over 130kg
ASA physical status 4 or 5
Planned use of intra or postoperative continuous intravenous lignocaine infusion
Uncontrolled hypertension (SBP >180mmHg) on admission
Poorly controlled atrial fibrillation (ventricular response rate >120/min) on admission
Uncontrolled heart failure
Intracranial surgery or raised intracranial pressure
History of haemorrhagic stroke
Severe impairment of liver function
Previous adverse reaction to ketamine
Documented complex regional pain syndrome
History of epilepsy or convulsions
History of psychosis, or of illicit drug use or known illegal activities
Previously randomised to the ROCKet trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of chronic post-surgical pain (CPSP) reported by the patient at telephone follow-up structured interview and adjudicated as CPSP by the endpoint adjudication committee. CPSP will be defined as pain reported by the patient in the area of the index surgery, experienced in the week prior to the 3 and 12 month follow up calls, which either was not present, or is different in site, nature or of greater intensity (VAS =2/10 above pre-operative pain score) than any pain present prior to surgery. Details of reported pain will be reviewed by three members of the EAC for blinded assessment of whether they meet the criteria for CPSP. EAC members will be clinicians practicing in the field of pain medicine with expertise in chronic pain assessment.[ 3 months post-surgery.]