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

NCT ID: NCT01312077

Last Updated: 2011-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Levobupivacaine infiltration

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.

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

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.

Control

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).

Group Type: OTHER

Intrathecal morphine

Intervention Type: DRUG

intrathecal morphine bolus 200 micrograms

Interventions

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.

Intervention Type: DRUG

Intrathecal morphine

intrathecal morphine bolus 200 micrograms

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cork University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cork University Hospital, Cork, Ireland

Principal Investigators

Denise M McCarthy, MB FCARCSI

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital

Locations

St Mary's Orthopaedic Hospital

Cork, , Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Denise M McCarthy, MB FCARCSI

Role: CONTACT

dmc_btown@yahoo.co.uk

353-87-2341254

Gabriella Iohom, MD PhD

Role: CONTACT

iohom@hotmail.com

353-21-4922135

Other Identifiers

THR-SMOH

Identifier Type: -

Identifier Source: org_study_id