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

Total Hip Arthroplasty Clinical Trial

Official title:

Postoperative Analgesia in Total Hip Replacement: a Comparison of the Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic With Intrathecal Morphine.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312077
• Other study ID #: THR-SMOH
• Status: Recruiting
• Phase: Phase 4
• First received: March 9, 2011
• Last updated: March 9, 2011
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: Cork University Hospital
• Contact: Denise M McCarthy, MB FCARCSI
• Phone: 353-87-2341254
• Email: dmc_btown[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Drug:
• Levobupivacaine
peri- and intraarticular surgical site infiltration 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 under the sterile surgical conditions and this will be left in situ in the wound. An elastomeric pump will deliver a continuous infusion of levobupivacaine 0.25% at 4ml/hr commencing 6 hours postoperatively and continuing for 24 hours.
• Intrathecal morphine
intrathecal morphine bolus 200 micrograms

Locations

Country	Name	City	State
Ireland	St Mary's Orthopaedic Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Cork University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of analgesia at 24 hours postoperatively as assessed by visual analogue score (VAS) for pain at rest and on movement.		24 hours postoperatively	No
Secondary	Opioid consumption in the first 48 hours postoperatively.		48 hours	No