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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000247673

Acronym

ROCKet Pilot Study

Enrollment

Registered

2014-03-07

Start date

2014-02-27

Completion date

2015-05-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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

Outcome results