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Clinical Trials/NCT01312415
NCT01312415
Unknown
Phase 4

A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

Cork University Hospital1 site in 1 country42 target enrollmentAugust 2010

Overview

Phase
Phase 4
Intervention
Levobupivacaine
Conditions
Total Knee Replacement
Sponsor
Cork University Hospital
Enrollment
42
Locations
1
Primary Endpoint
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
Last Updated
15 years ago

Overview

Brief Summary

Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.

We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
June 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for unilateral total knee replacement
  • Consent to spinal anaesthesia
  • ASA Grade I to III

Exclusion Criteria

  • Patient refusal
  • Mini-Mental Score \< 25 (see appendix 3)
  • Allergy to bupivacaine, morphine, paracetamol, diclofenac
  • Skin lesions/infection at site of injection
  • Uncorrected renal dysfunction
  • Coagulation disorders
  • chronic pain condition other than knee pain

Arms & Interventions

levobupivacaine infiltration

Patients will receive spinal anaesthesia with intrathecal bupivacaine (17.5 or 15 mg) without morphine, and will receive peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% at 8am the following morning.

Intervention: Levobupivacaine

Control

Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).

Intervention: Intrathecal morphine

Outcomes

Primary Outcomes

Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement

Time Frame: 24 hours postoperatively

Secondary Outcomes

  • Opioid consumption in total in the first 48 hours postoperatively(48 hours postoperatively)

Study Sites (1)

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