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

NCT01312077 | Unknown Phase 4

• 1 other identifier: THR-SMOH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

total hip arthroplasty; total hip replacement; local infiltration analgesia; wound infusion; patients undergoing total hip replacement (total hip arthroplasty)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid consumption in the first 48 hours postoperatively.

  48 hours

Study Arms (2)

Levobupivacaine infiltration

EXPERIMENTAL

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.

Drug: Levobupivacaine

Control

OTHER

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).

Drug: Intrathecal morphine

Interventions

Levobupivacaine 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.

Levobupivacaine infiltration

Intrathecal morphine DRUG

intrathecal morphine bolus 200 micrograms

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

St Mary's Orthopaedic Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Denise M McCarthy, MB FCARCSI

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise M McCarthy, MB FCARCSI

CONTACT

353-87-2341254; dmc_btown@yahoo.co.uk

Gabriella Iohom, MD PhD

CONTACT

353-21-4922135; iohom@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 10, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

IE (1)