The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
- Registration Number
- NCT01312415
- Lead Sponsor
- Cork University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- Patients scheduled for unilateral total knee replacement
- Consent to spinal anaesthesia
- ASA Grade I to III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Intrathecal morphine 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). levobupivacaine infiltration Levobupivacaine 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.
- Primary Outcome Measures
Name Time Method Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement 24 hours postoperatively
- Secondary Outcome Measures
Name Time Method Opioid consumption in total in the first 48 hours postoperatively 48 hours postoperatively
Trial Locations
- Locations (1)
St Mary Orthopedic Hospital
🇮🇪Cork, Ireland
St Mary Orthopedic Hospital🇮🇪Cork, Ireland