Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Drug: ropivacaine, ketorolac and epinephrine Drug: morphine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty |
- Morphine consumption [ Time Frame: The first 48 postoperative hours ] [ Designated as safety issue: No ]
- Pain intensity [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
- Knee function [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
- Time to home readiness [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
- Hospital stay [ Time Frame: 0-2 weeks ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
- Patient satisfaction [ Time Frame: 0-3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Per Essving, MD | +4619602100 | per.essving@orebroll.se |
| Contact: Kjell Axelsson, Professor | +4619602100 | kjell.axelsson@orebroll.se |
| Sweden | |
| Dept. of Orthopedic Surgery | Recruiting |
| Orebro, Sweden, SE-70185 | |
| Contact: Per Essving, MD +4619602100 per.essving@orebroll.se | |
| Contact: Kjell Axelsson, Professor +4619602100 kjell.axelsson@orebroll.se | |
| Principal Investigator: Kjell Axelsson, Professor | |
More Information
No publications provided
| Responsible Party: | Professor Kjell Axelsson, University Hospital Orebro |
| ClinicalTrials.gov Identifier: | NCT00992082 History of Changes |
| Other Study ID Numbers: | RAK-Spinal |
| Study First Received: | October 7, 2009 |
| Last Updated: | October 8, 2009 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by University Hospital Orebro:
|
Postoperative pain Local Infiltration Analgesia Knee arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Epinephrine Epinephryl borate Morphine Ketorolac Ketorolac Tromethamine Ropivacaine Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 18, 2013