The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty - Full Text View

Sponsors and Collaborators:	Duke University Pfizer
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00620828

Purpose

The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.

Condition	Intervention	Phase
Osteoarthritis	Other: Placebo saline injection Drug: Ropivicaine 0.5%	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis Surgery

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

VAS Pain score, knee motion, ambulation effort, time to SLR, Ramsey sedation score, total narcotic use [ Time Frame: 24 hours post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Block Negative: Placebo Comparator Subjects receive intra-op saline injection per protocol	Other: Placebo saline injection 20 cc of sterile, injectable saline
Block Positive: Experimental Subjects receive intra-op Ropivicaine 0.5% injection per protocol	Drug: Ropivicaine 0.5% Ropivicaine

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The subject is scheduled to undergo elective total knee replacement at Duke University Hospital.
The subject has signed the written consent form.

Exclusion Criteria:

Known allergy to ropivacaine or hydromorphone.
Known history of narcotic abuse or alcohol abuse.
Known history of chronic pain.
Known diagnosis of peripheral neuropathy or complex regional pain syndrome.
Significant impediment to physical therapy participation.
The surgery is a revision case.
Patient is undergoing bilateral Total Knee Replacement.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620828

Contacts

Contact: Michael P Bolognesi, M.D.	(919) 668-4732	michael.bolognesi@duke.edu
Contact: David Attarian, M.D.	(919) 668-4732	david.attarian@duke.edu

Locations

United States, North Carolina
Duke University Adult Reconstructive Surgery	Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael P Bolognesi, M.D. 919-668-4732 michael.bolognesi@duke.edu

Sponsors and Collaborators

Duke University

Pfizer

Investigators

Principal Investigator:

Michael P Bolognesi, M.D.

Duke University

More Information

Publications:

Ben-David B, Schmalenberger K, Chelly JE. Analgesia after total knee arthroplasty: is continuous sciatic blockade needed in addition to continuous femoral blockade? Anesth Analg. 2004 Mar;98(3):747-9, table of contents.

Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6.

Davies AF, Segar EP, Murdoch J, Wright DE, Wilson IH. Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Br J Anaesth. 2004 Sep;93(3):368-74. Epub 2004 Jul 9.

Edwards ND, Wright EM. Continuous low-dose 3-in-1 nerve blockade for postoperative pain relief after total knee replacement. Anesth Analg. 1992 Aug;75(2):265-7.

Hirst GC, Lang SA, Dust WN, Cassidy JD, Yip RW. Femoral nerve block. Single injection versus continuous infusion for total knee arthroplasty. Reg Anesth. 1996 Jul-Aug;21(4):292-7.

Klasen JA, Opitz SA, Melzer C, Thiel A, Hempelmann G. Intraarticular, epidural, and intravenous analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 1999 Nov;43(10):1021-6.

Lau HP, Yip KM, Jiang CC. Regional nerve block for total knee arthroplasty. J Formos Med Assoc. 1998 Jun;97(6):428-30.

Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30.

Mauerhan DR, Campbell M, Miller JS, Mokris JG, Gregory A, Kiebzak GM. Intra-articular morphine and/or bupivacaine in the management of pain after total knee arthroplasty. J Arthroplasty. 1997 Aug;12(5):546-52.

Nechleba J, Rogers V, Cortina G, Cooney T. Continuous intra-articular infusion of bupivacaine for postoperative pain following total knee arthroplasty. J Knee Surg. 2005 Jul;18(3):197-202.

Niskanen RO, Strandberg N. Bedside femoral block performed on the first postoperative day after unilateral total knee arthroplasty: a randomized study of 49 patients. J Knee Surg. 2005 Jul;18(3):192-6.

Pham Dang C, Gautheron E, Guilley J, Fernandez M, Waast D, Volteau C, Nguyen JM, Pinaud M. The value of adding sciatic block to continuous femoral block for analgesia after total knee replacement. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):128-33.

Szczukowski MJ Jr, Hines JA, Snell JA, Sisca TS. Femoral nerve block for total knee arthroplasty patients: a method to control postoperative pain. J Arthroplasty. 2004 Sep;19(6):720-5.

Tanaka N, Sakahashi H, Sato E, Hirose K, Ishii S. The efficacy of intra-articular analgesia after total knee arthroplasty in patients with rheumatoid arthritis and in patients with osteoarthritis. J Arthroplasty. 2001 Apr;16(3):306-11.

Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44.

Responsible Party:	Duke University Medical Center ( Michael P. Bolognesi/Director of Adult Reconstructive Surgery )
Study ID Numbers:	00000233, SPS# 139715
Study First Received:	February 12, 2008
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00620828 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases
Pain, Postoperative

ClinicalTrials.gov processed this record on September 04, 2009