Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344395
• Other study ID #: 2009-016445-25
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2010
• Last updated: January 21, 2013
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Cummulative morphine comsumption postoperatively	24 hours postoperatively	No
Secondary	Pain intensity	Pain intensity measured on the visual analog scale (VAS) at rest and during walking	24 hours postoperatively	No
Secondary	Postoperative nausea	Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)	24 hours postoperatively	No