Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Region Örebro County

Status: Unknown

Conditions: Osteoarthritis

Treatments: Drug: ropivacaine, ketorolac and epinephrine; Drug: morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00992082

RAK-Spinal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups

Group LIA

Active Comparator group

Description:

Local Infiltration Analgesia

Treatment:

Drug: ropivacaine, ketorolac and epinephrine

Group M

Active Comparator group

Description:

Intrathecal morphine

Treatment:

Drug: morphine