Randomised prospective, double-blinded study comparing the effectiveness of administering morphine patient controlled analgesia (PCA) to morphine and ketamine PCA for patients undergoing a total knee replacement.

In patients undergoing a total knee replacement, does adding ketamine to a morphine patient controlled analgesia (PCA) lead to improved analgesia as measured by VNRS? A randomised, prospective, double-blinded study.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001036707

Enrollment

530

Registered

2013-09-18

Start date

2004-07-01

Completion date

2005-07-31

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

Total Knee Replacements are associated with a frequent incidence of intense postoperative pain, particularly during early attempts at mobilisation. This trial will investigate the effective of adding Ketamine to a Morphine Patient Controlled Analgesia (PCA) system in order to improve analgesic efficacy, focusing on the first 48 hours. It will also measure side effects that might emerge from adding Ketamine to a Morphine PCA, the level of patient satisfaction with their PCA, and whether the addition of Ketamine leads to less PCA use.

Interventions

A Morphine 1mg/mL + Ketamine 2mg/mL patient controlled analgesia (PCA) administered intravenously, with 5 minute lockout, and 10mL hourly limit to be commenced after adequate pain relief is achieved in recovery with a verbal numerical rating scale of <4, post total knee replacement. PCA to cease at the discretion of the Acute Pain Service as is the usual protocol at the institution of this study, usually 48 hours postoperatively.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Elective patients undergoing a Total Knee Replacement 18 years or older Would be able to understand the use of a Patient Controlled Analgesia (PCA) system

Exclusion criteria

An allergy to morphine or ketamine Patient inability to use a PCA Pre-existing neurological or psychiatric illnesses Evidence of severe cardiovascular, renal, hematologic or hepatic disease Patients unsuitable for the study’s standardised anaesthetic technique Patients requiring other analgesic drugs or regional techniques which may affect the appreciation of pain Alcohol and opioid dependent patients Patients with a history of chronic pain

Outcome results