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Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ropivacaine, ketorolac and epinephrine
morphine
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Postoperative pain, Local Infiltration Analgesia, Knee arthroplasty

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Orthopedic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group LIA

Group M

Arm Description

Local Infiltration Analgesia

Intrathecal morphine

Outcomes

Primary Outcome Measures

Morphine consumption

Secondary Outcome Measures

Pain intensity
Knee function
Time to home readiness
Hospital stay
Side effects
Patient satisfaction

Full Information

First Posted
October 7, 2009
Last Updated
October 8, 2009
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT00992082
Brief Title
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Official Title
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Region Örebro County

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Postoperative pain, Local Infiltration Analgesia, Knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group LIA
Arm Type
Active Comparator
Arm Description
Local Infiltration Analgesia
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
Intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
ropivacaine, ketorolac and epinephrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
The first 48 postoperative hours
Secondary Outcome Measure Information:
Title
Pain intensity
Time Frame
0-3 months
Title
Knee function
Time Frame
0-3 months
Title
Time to home readiness
Time Frame
0-2 weeks
Title
Hospital stay
Time Frame
0-2 weeks
Title
Side effects
Time Frame
0-3 months
Title
Patient satisfaction
Time Frame
0-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Essving, MD
Phone
+4619602100
Email
per.essving@orebroll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kjell Axelsson, Professor
Phone
+4619602100
Email
kjell.axelsson@orebroll.se
Facility Information:
Facility Name
Dept. of Orthopedic Surgery
City
Orebro
ZIP/Postal Code
SE-70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Essving, MD
Phone
+4619602100
Email
per.essving@orebroll.se
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Professor
Phone
+4619602100
Email
kjell.axelsson@orebroll.se
First Name & Middle Initial & Last Name & Degree
Kjell Axelsson, Professor

12. IPD Sharing Statement

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Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

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