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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01312077
Enrollment
50
Registered
2011-03-10
Start date
2010-10-31
Completion date
2011-06-30
Last updated
2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

Keywords

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

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.

Interventions

DRUGLevobupivacaine

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.

DRUGIntrathecal morphine

intrathecal morphine bolus 200 micrograms

Sponsors

Cork University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Opioid consumption in the first 48 hours postoperatively.48 hours

Countries

Ireland

Contacts

Primary ContactDenise M McCarthy, MB FCARCSI
dmc_btown@yahoo.co.uk353-87-2341254
Backup ContactGabriella Iohom, MD PhD
iohom@hotmail.com353-21-4922135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026