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

NCT00270322 | Terminated Phase 4

• 1 other identifier: TKR-1.CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative; Osteoarthritis

Keywords

total knee replacement; orthopedic surgery; post operative analgesia; continuous epidural; patients controlled analgesia; morphine; combined spinal epidural anesthesia; anesthesia; analgesia; epidural marcaine; epidural fentanyl; pain

Outcome Measures

Primary Outcomes (2)

• Visual analog scale (VAS) (rest/movement) during first 24 hours post-operation

• Total dose of rescue analgesics during first 24 hours post-operation

Secondary Outcomes (4)

• VAS (rest/movement) + total dose rescue analgesics after 24 hours post-operation until discharge

• Patient outcome questionnaire

• Physiotherapy performance VAS (rest/walking, passive extension, maximal angle, knee flexion/extension)

• Adverse reactions, complications

Interventions

Marcaine 0.166% + Fentanyl 3.33 mcg/ml DRUG

Morphine sulphate DRUG

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (6)

• 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. doi: 10.1097/00003086-199610000-00028.

  PMID: 8895639 BACKGROUND

• 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. doi: 10.1007/s004020050407.

  PMID: 10447620 BACKGROUND

• 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. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• 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. doi: 10.1097/00000539-199807000-00019.

  PMID: 9661552 BACKGROUND

• 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. doi: 10.1001/jama.1995.03530230060032.

  PMID: 7500539 BACKGROUND

• 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. doi: 10.1097/00000542-200506000-00020.

  PMID: 15915033 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis; Agnosia; Pain

Interventions

Bupivacaine; Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ruth Edery, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 26, 2005
• Study Start: January 1, 2006
• Study Completion: March 1, 2007
• Last Updated: April 11, 2007

Record last verified: 2006-05

Locations

IL (1)