Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00992082
• Other study ID #: RAK-Spinal
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 8, 2009
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2009
• Source: University Hospital Orebro
• Contact: Per Essving, MD
• Phone: +4619602100
• Email: per.essving[@]orebroll.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Sweden	Dept. of Orthopedic Surgery	Orebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption		The first 48 postoperative hours	No
Secondary	Pain intensity		0-3 months	No
Secondary	Knee function		0-3 months	No
Secondary	Time to home readiness		0-2 weeks	No
Secondary	Hospital stay		0-2 weeks	No
Secondary	Side effects		0-3 months	Yes
Secondary	Patient satisfaction		0-3 months	No