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OpenTrials
Completed

NCT Number: NCT01344395

Use of Local Infiltration Analgesia Following Total Hip Arthroplasty

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine and ketorolac

Drug

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

Drug

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

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours postoperatively

    Cummulative morphine comsumption postoperatively

Secondary outcomes

  1. Pain intensity

    Time frame: 24 hours postoperatively

    Pain intensity measured on the visual analog scale (VAS) at rest and during walking

  2. Postoperative nausea

    Time frame: 24 hours postoperatively

    Number of episodes of nausea measured on a 3 points rating scale (mild, moderate and severe)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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