The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312077
|Contact: Denise M McCarthy, MB FCARCSIemail@example.com|
|Contact: Gabriella Iohom, MD PhDfirstname.lastname@example.org|
|St Mary's Orthopaedic Hospital||Recruiting|
|Principal Investigator:||Denise M McCarthy, MB FCARCSI||Cork University Hospital|