Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

Osteoarthritis Clinical Trial

Official title:

Pain Treatment After Total Knee Replacement - Continuous Epidural Versus Intravenous Patient Controlled Analgesia With Morphine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00270322
• Other study ID #: TKR-1.CTIL
• Status: Terminated
• Phase: Phase 4
• First received: December 23, 2005
• Last updated: April 10, 2007
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2006
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The study purpose is to compare the effectiveness of different methods for post-operative pain treatment after total knee replacement.

Description:

Total knee replacement (TKR) is known to be one of the most painful surgical procedures. Many treatments have been used post TKR: IV opioids, epidural infusions, peripheral nerve blocks. No one method has been recognised as the best one.

In this study we will compare two well established methods of pain treatment:

1. continuous infusion of local anesthetics + opioids into the epidural space,

2. patient controlled analgesia with IV Morphine.

The study design is double blind.

Patients will have a combined spinal-epidural anesthesia for the operation and then will be connected to 2 different pumps, one to the epidural catheter and one to the intravenous catheter, for the first 24 hours post-operatively.

Pain scores, total analgesic medications other than study medications, adverse reactions to study medications, complications and patient satisfaction will be followed by blinded observers and compared between groups.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Age: 55 to 85 years

• Osteoarthritis

• Primary unilateral total knee replacement

• American Society of Anesthesiologists (ASA) I-III

• Successful spinal epidural anesthesia for surgery

Exclusion Criteria:

• Any cause for knee replacement other than osteoarthritis

• Total knee revision (re-do)

• Any contraindication for regional anesthesia

• Abnormal coagulation studies

• Thrombocytopenia less than 100,000/cc

• Chronic renal failure (creatinine [cr] < 1.8)

• Neurological disease involving lower extremities

• Major surgery during the last 2 weeks pre-operatively

• Current or past drug or alcohol abuse

• Allergy to study medications

• Post-operative bleeding over 2000 cc/24 hours

• Postdural puncture headache after anesthesia performance

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain, Postoperative

Intervention

Drug:
• Marcaine 0.166% + Fentanyl 3.33 mcg/ml

• Morphine sulphate

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. — View Citation

Forst J, Wolff S, Thamm P, Forst R. Pain therapy following joint replacement.A randomized study of patient-controlled analgesia versus conventional pain therapy. Arch Orthop Trauma Surg. 1999;119(5-6):267-70. — View Citation

Foss NB, Kristensen MT, Kristensen BB, Jensen PS, Kehlet H. Effect of postoperative epidural analgesia on rehabilitation and pain after hip fracture surgery: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2005 Jun;102(6):1197-204. — View Citation

Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. Review. — View Citation

Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. — View Citation

Williams-Russo P, Sharrock NE, Haas SB, Insall J, Windsor RE, Laskin RS, Ranawat CS, Go G, Ganz SB. Randomized trial of epidural versus general anesthesia: outcomes after primary total knee replacement. Clin Orthop Relat Res. 1996 Oct;(331):199-208. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation
Primary	Total dose of rescue analgesics during first 24 hours post-operation
Secondary	VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge
Secondary	Patient outcome questionnaire
Secondary	Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)
Secondary	Adverse reactions, complications