Reduction Of Chronic Post-surgical Pain with Ketamine – A Pilot Study
A pilot study for a multicentre double-blind placebo controlled randomized Phase 4 study of the effect of ketamine on the development of chronic post-surgical pain in patients undergoing elective abdominal or non-cardiac thoracic surgery under general anaesthesia.
Austin Health
80 participants
Feb 27, 2014
Interventional
Conditions
Summary
There is a well established physiological basis for the proposition that a potent NMDA receptor antagonist such as the widely available drug ketamine given peri-operatively may reduce the development of chronic postsurgical pain in patients undergoing major surgery, and this proposition is supported by available data pooled from small placebo controlled published studies, and a large study on N2O. The potential benefits of this in reducing the burden of chronic pain in the community are substantial. A large multicentre randomized trial is needed in patients undergoing major surgery to determine whether chronic post-surgical pain is reduced using intravenous ketamine given peri-operatively.
Eligibility
Inclusion Criteria1
- 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 Criteria12
- 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
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Interventions
The effect of intravenous ketamine given prior to and for up to 24 hours following surgical incision on the prevalence and severity of chronic post-surgical pain at 4-6 months postoperatively. Ketamine dosage is 0. 5mg/kg bolus, followed by 0.25 mg/kg/hr intra-operatively. then 0.1 mg/kg/hr continued for 24 hour
Locations(1)
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ACTRN12614000247673