Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

October 8, 2009 updated by: Region Örebro County
The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Orebro, Sweden, SE-70185
        • Recruiting
        • Dept. of Orthopedic Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kjell Axelsson, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for total knee arthroplasty under spinal anesthesia.
  • Aged 40-85 yrs.
  • ASA physical status I-III and mobility indicating normal postoperative mobilization.

Exclusion Criteria:

  • Known allergy or intolerance to one of the study drugs.
  • Serious liver-, heart- or renal decease.
  • Rheumatoid arthritis.
  • Chronic pain or bleeding disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group LIA
Local Infiltration Analgesia
Drug: ropivacaine, ketorolac and epinephrine
Spinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
Active Comparator: Group M
Intrathecal morphine
Drug: morphine
Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphine consumption
Time Frame: The first 48 postoperative hours
The first 48 postoperative hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity
Time Frame: 0-3 months
0-3 months
Knee function
Time Frame: 0-3 months
0-3 months
Time to home readiness
Time Frame: 0-2 weeks
0-2 weeks
Hospital stay
Time Frame: 0-2 weeks
0-2 weeks
Side effects
Time Frame: 0-3 months
0-3 months
Patient satisfaction
Time Frame: 0-3 months
0-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2009

Last Update Submitted That Met QC Criteria

October 8, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAK-Spinal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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