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

Cork University Hospital

Status and phase: Unknown; Phase 4

Conditions: Total Knee Replacement

Treatments: Drug: Intrathecal morphine; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01312415

TKR-SMOH

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

levobupivacaine infiltration

Experimental group

Description:

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.

Treatment:

Drug: Levobupivacaine

Control

Other group

Description:

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).

Treatment:

Drug: Intrathecal morphine