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Clinical Trials/NCT01312077
NCT01312077
Unknown
Phase 4

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

Cork University Hospital1 site in 1 country50 target enrollmentOctober 2010

Overview

Phase
Phase 4
Intervention
Levobupivacaine
Conditions
Total Hip Arthroplasty
Sponsor
Cork University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Quality of analgesia at 24 hours postoperatively as assessed by visual analogue score (VAS) for pain at rest and on movement.
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Arms & Interventions

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: 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: Intrathecal morphine

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Opioid consumption in the first 48 hours postoperatively.(48 hours)

Study Sites (1)

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