drugset / Trial / NCT01312415

The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

NCT01312415

Phase 4 Unknown 42 enrolled Cork University Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2010-08
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Levobupivacaine Other / unclassified 2 mg/kg Other
Subject Levobupivacaine Other / unclassified 15 ml Other
Subject Morphine Other / unclassified 0.3 mg Intrathecal
Background Bupivacaine Other / unclassified 15 mg Intrathecal
Background Bupivacaine Other / unclassified 17.5 mg Intrathecal
Background Epinephrine Other / unclassified 0.5 mg

Indications

No indication recorded.