The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement
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|ClinicalTrials.gov Identifier: NCT01312077|
Recruitment Status : Unknown
Verified March 2011 by Cork University Hospital.
Recruitment status was: Recruiting
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Arthroplasty||Drug: Levobupivacaine Drug: Intrathecal morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Postoperative Analgesia in Total Hip Replacement: a Comparison of the Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic With Intrathecal Morphine.|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
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.
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.
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
- 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 ]
- Opioid consumption in the first 48 hours postoperatively. [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312077
|Contact: Denise M McCarthy, MB FCARCSIfirstname.lastname@example.org|
|Contact: Gabriella Iohom, MD PhDemail@example.com|
|St Mary's Orthopaedic Hospital||Recruiting|
|Principal Investigator:||Denise M McCarthy, MB FCARCSI||Cork University Hospital|