Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac

The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Postoperative
• Intervention / Treatment: Drug: ropivacaine and ketorolac; Drug: Ketorolac

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for total hip arthroplasty
• Patients > 18 years of age
• Signed written informed consent
• Spinal anaesthesia

Exclusion Criteria:

• Allergy towards study drugs
• Rheumatoid arthritis
• Body Mass Index > 35 (severe obesity)
• Pregnancy or nursing women
• Regular opioid use
• Patients who can not read or understand danish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RK-group	Drug: ropivacaine and ketorolac; The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively
Active Comparator: K-group	Drug: Ketorolac; The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Cummulative morphine comsumption postoperatively	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity measured on the visual analog scale (VAS) at rest and during walking	24 hours postoperatively
Postoperative nausea	Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)	24 hours postoperatively

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Lundbeck Foundation
• Investigators: Principal Investigator: Kjeld Søballe, Professor, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 21, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ketorolac; Ropivacaine; Ketorolac Tromethamine
• Other Study ID Numbers: 2009-016445-25