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

Purpose

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.

Condition	Intervention	Phase
Total Hip Arthroplasty	Drug: Levobupivacaine Drug: Intrathecal morphine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Postoperative Analgesia in Total Hip Replacement: a Comparison of the Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic With Intrathecal Morphine.

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement

Drug Information available for: Morphine sulfate Bupivacaine

U.S. FDA Resources

Further study details as provided by Cork University Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Opioid consumption in the first 48 hours postoperatively. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
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).	Drug: Intrathecal morphine intrathecal morphine bolus 200 micrograms

Arms

Assigned Interventions

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.

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.

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).

Drug: Intrathecal morphine

intrathecal morphine bolus 200 micrograms

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312077

Contacts

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

Locations

Ireland
St Mary's Orthopaedic Hospital	Recruiting
Cork, Ireland

Sponsors and Collaborators

Cork University Hospital

Investigators

Principal Investigator:

Denise M McCarthy, MB FCARCSI

Cork University Hospital

More Information

No publications provided

Responsible Party:	Denise McCarthy, Anaesthesia Specialist Registrar, Cork University Hospital, Cork, Ireland
ClinicalTrials.gov Identifier:	NCT01312077 History of Changes
Other Study ID Numbers:	THR-SMOH
Study First Received:	March 9, 2011
Last Updated:	March 9, 2011
Health Authority:	Ireland: Research Ethics Committee

Keywords provided by Cork University Hospital:

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

Additional relevant MeSH terms:

Analgesics
Morphine
Anesthetics, Local
Levobupivacaine
Bupivacaine
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013

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