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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Cork University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01312077
First received: March 9, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 9, 2011
March 9, 2011
October 2010
June 2011   (final data collection date for primary outcome measure)
Quality of analgesia at 24 hours postoperatively as assessed by visual analogue score (VAS) for pain at rest and on movement. [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Opioid consumption in the first 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement
Postoperative Analgesia in Total Hip Replacement: a Comparison of the Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic With Intrathecal Morphine.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Total Hip Arthroplasty
  • 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.
  • Drug: Intrathecal morphine
    intrathecal morphine bolus 200 micrograms
  • Experimental: 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.
    Intervention: Drug: Levobupivacaine
  • 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).
    Intervention: Drug: Intrathecal morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Denise M McCarthy, MB FCARCSI 353-87-2341254 dmc_btown@yahoo.co.uk
Contact: Gabriella Iohom, MD PhD 353-21-4922135 iohom@hotmail.com
Ireland
 
NCT01312077
THR-SMOH
No
Denise McCarthy, Anaesthesia Specialist Registrar, Cork University Hospital, Cork, Ireland
Cork University Hospital
Not Provided
Principal Investigator: Denise M McCarthy, MB FCARCSI Cork University Hospital
Cork University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP