Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

NCT ID: NCT00992082

Last Updated: 2009-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-08-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group LIA

Local Infiltration Analgesia

Group Type: ACTIVE_COMPARATOR

ropivacaine, ketorolac and epinephrine

Intervention Type: DRUG

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.

Group M

Intrathecal morphine

Group Type: ACTIVE_COMPARATOR

morphine

Intervention Type: DRUG

Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

Interventions

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.

Intervention Type: DRUG

morphine

Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Orebro

Locations

Dept. of Orthopedic Surgery

Örebro, Örebro County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Per Essving, MD

Role: CONTACT

per.essving@orebroll.se

+4619602100

Kjell Axelsson, Professor

Role: CONTACT

kjell.axelsson@orebroll.se

+4619602100

Facility Contacts

Per Essving, MD

Role: primary

per.essving@orebroll.se

+4619602100

Kjell Axelsson, Professor

Role: backup

kjell.axelsson@orebroll.se

+4619602100

Other Identifiers

RAK-Spinal

Identifier Type: -

Identifier Source: org_study_id