A comparison of two techniques for pain relief following Knee Replacement Surgery

A Prospective, Randomised, Controlled Trial to Determine if the Addition of Intrathecal Morphine to Local Anaesthetic Infiltration Improves Analgesia and Patient Outcomes Following Primary, Unilateral Knee Replacement

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000364178

Enrollment

Registered

2019-03-07

Start date

2019-05-01

Completion date

2020-01-01

Last updated

2019-07-15

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

Conditions

None listed

Brief summary

To compare the outcomes (both analgesic and functional outcomes) between two methods of analgesia for knee replacement surgery, and determine if the addition of intrathecal morphine to a standardised regime including large dose local infiltration anaesthesia is equivalent, better, or worse than current best practice.

Interventions

200 micrograms of intrathecal morphine administered immediately before knee replacement surgery. This is in addition to 3.0mL 0.5% plain bupivacaine and a propofol infusion intraoperatively for either sedation or general anaesthesia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

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

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

Elective primary unilateral total knee arthroplasty Age 40-75 years ASA 1-3 Ability to self mobilise

Exclusion criteria

BMI>40 Previous involvement in this study. Neuropathic pain or opioid tolerance (defined as use of >30mg oral morphine/day or equivalent – fentanyl patch 12mcg/hr, buprenorphine patch 20mcg/hr, oral oxycodone >20mg/day) History of stroke or major neurological deficit, sensory and motor disorders in the operated limb Contraindication to spinal anaesthesia (including coagulopathy, sepsis, local infection, patient refusal, spinal defects, previous laminectomy, use of anticoagulant/antiplatelet medications as per ASRA guidelines) Contraindication to any of the study drugs (including allergy, significant renal or hepatic disease, NSAID induced asthma)

Outcome results