The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement

Phase 4

• Conditions: Total Hip Arthroplasty
• Interventions: Drug: Intrathecal morphine; Drug: Levobupivacaine

• Registration Number: NCT01312077
• Lead Sponsor: Cork University Hospital

Brief Summary

Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Status Verified: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Last Update Submitted: 2011-03-09
• Study First Posted: 2011-03-10
• Last Update Posted: 2011-03-10
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Patient refusal
• Mini-Mental Score < 25
• Allergy to bupivacaine, morphine, paracetamol, diclofenac
• Skin lesions/infection at site of injection
• Uncorrected renal dysfunction
• Coagulation disorders
• chronic pain condition other than hip 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 (0.2 mg).
Levobupivacaine infiltration	Levobupivacaine	Patients will receive spinal anaesthesia with intrathecal bupivacaine, and will receive peri- and intraarticular surgical site infiltration during surgery and before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline. A catheter will be placed by the surgeon before closure and this will be left in situ in the wound. The catheter will be sited under the fascia lata exiting antero-superior to the incision. A bacterial filter will be attached and it will be connected to an elastomeric pump which will deliver a continuous infusion of levobupivacaine 0.25% at 4ml/hr commencing 6 hours postoperatively and continuing for 24 hours.

Primary Outcome Measures

Name	Time	Method
Quality of analgesia at 24 hours postoperatively 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 the first 48 hours postoperatively.	48 hours

Trial Locations

Locations (1)

St Mary's Orthopaedic Hospital; 🇮🇪 Cork, Ireland