Reduction Of Chronic Post-surgical Pain with Ketamine – A Pilot Study

Phase 3

Completed

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

• Registration Number: ACTRN12614000247673
• Lead Sponsor: Austin Health

Brief Summary

Chronic post-surgical pain (CPSP) is a common and debilitating complication of major surgery. We undertook a pilot study for a proposed large multicentre placebo controlled randomized trial of intravenous perioperative ketamine to reduce the incidence of CPSP. Ketamine at low doses or placebo was administered to 80 patients undergoing abdominal or thoracic surgery under general anaesthesia. The primary endpoint was CPSP in the area of the surgery reported at 6 month telephone follow up using a structured questionnaire. Four patients in the treatment group and 3 in the control group reported ongoing analgesic use to treat CPSP and 2 patients in each group reported their worst pain in the previous 24 hours at more than 3/10 at 6 months. There were no significant differences in adverse event rates, quality of recovery scores, cumulative morphine equivalents consumption or total pain scores in the first 72 hours. Regardless of treatment allocation, CPSP incidence was associated with poorer psychological well being using Kessler K-10 score, and with greater disability on the World Health Organization Disability Assessment Scale. A large adequately powered trial is feasible using this population and methodology.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Study Completion: 2015-12-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients undergoing elective abdominal or non-cardiac thoracic surgery under general anaesthesia involving a skin incision at least 8 cm in length and a hospital stay of at least one night postoperatively.

Exclusion Criteria

Patients unable to provide informed consent
Patients with poor English language comprehension
Patients who are pregnant
Body mass index (BMI) over 40 kg/m2 or weight over 130kg
ASA grade 4 or 5.
Uncontrolled hypertension (SBP over 180 mmHg) or heart failure
Intracranial surgery
History of haemorrhagic stroke
Previous adverse reaction to ketamine
Patients with a documented chronic pain syndrome identified using the mBPI
Patients with epilepsy or history of convulsions
Patients with a history of psychiatric problems or drug abuse or illegal activities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of chronic post-surgical wound-related pain reported by the patient using a structured questionnaire incorporating the modified brief pain inventory (mBPI).[4-6 months postoperatively.]

Secondary Outcome Measures

Name	Time	Method
The mean severity of chronic post-surgical wound-related pain measured using a Visual Analog Scale (0-100).[4-6 months postoperatively];Quality of life estimates using the WHODAS and Kessler K-10 Depression scale, and their relationship to pain prevalence and severity[4-6 months after surgery.];The severity of acute postoperative pain measured using a Visual Analog Scale (0-100).[In the first 24, 48 and 72 hours postoperative];Opioid and other analgesic consumption[The first 24, 48 and 72 hours postoperative];The relationship of the severity of acute postoperative pain to chronic post surgical pain prevalence and severity using a Visual Analog Scale (0-100). [4-6 months postoperative]