Not Yet RecruitingPhase 4ACTRN12619000364178

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


Sponsor

Mater and St Vincents Health

Enrollment

64 participants

Start Date

May 1, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Inclusion Criteria4

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

Exclusion Criteria12

  • 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)

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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

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.


Locations(1)

Mater Sydney - North Sydney

NSW, Australia

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