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

This study is not yet open for patient recruitment.
Verified by Rambam Health Care Campus August 2005

Sponsored by: Rambam Health Care Campus
Information provided by: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00270322

Purpose

The study purpose is to compare the effectiveness of different methods for post operative pain treatment after total knee replacement.
Condition Intervention Phase
Total Knee Replacement
Orthopedic Surgery
Pain, Postoperative
Osteoarthritis
 Drug: Marcaine 0.166% + Fentanyl 3.33 mcg/ml
 Drug: Morphine sulphate
Phase IV

MedlinePlus related topics:  Osteoarthritis;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Rambam Health Care Campus:
Primary Outcomes: (1) Visual analog scale (VAS)(in rest and movement) during first 24 hours post operation; (2) Total dose of rescue analgesics during first 24 hours post operation
Secondary Outcomes: (1) Visual analog scale (in rest and movement) after 24 hours post operation and until discharge; (2) Total dose of rescue analgesics after 24 hours post operation and until discharge; (3) Patient outcome questionnaire; (4) Physiotherapy performance throughout hospital stay (VAS-rest and walking, passive extension, maximal angle, knee flexion and extension); (5) Adverse reactions; (6) complications
Expected Total Enrollment:  80

Study start: January 2006

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.

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.

Eligibility

Ages Eligible for Study:  55 Years   -   85 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • informed consent
  • age: 55 to 85 years
  • Osteoarthritis
  • primary unilateral total knee replacement
  • 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 (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
  • post dural puncture headache after anesthesia performance

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00270322

Ruth Edery, MD      972-50-2065873    r_edery@rambam.health.gov.il
Miri Foox      972-50-1555    miri_f@rambam.health.gov.il

Israel
      RAMBAM Health Care Campus, Haifa,  31096,  Israel
Ruth Edery, MD  972-50-2065873    r_edery@rambam.health.gov.il 
Ruth Edery, MD,  Principal Investigator

Study chairs or principal investigators

Ruth Edery, MD,  Principal Investigator,  Rambam Health Care Campus   

More Information

Publications

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.

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.

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.

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.

[No authors listed] 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.

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.

Study ID Numbers:  TKR-1.CTIL
Last Updated:  December 23, 2005
Record first received:  December 23, 2005
ClinicalTrials.gov Identifier:  NCT00270322
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10

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