NCT00620828

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

May 3, 2013

Completed
Last Updated

June 3, 2015

Status Verified

March 1, 2013

Enrollment Period

1.1 years

First QC Date

February 12, 2008

Results QC Date

June 17, 2010

Last Update Submit

June 2, 2015

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Score

    Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).

    Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection

Secondary Outcomes (4)

  • Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption

    4 hours to 24 hours post-op

  • Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance

    24 hours post-op

  • Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion

    24 hours post-op

  • Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise

    4 hours, 8 hours, 12 hours and 24 hours post-op

Study Arms (2)

Block Negative

PLACEBO COMPARATOR

Subjects receive intra-op saline injection per protocol

Other: Placebo saline injection

Block Positive

EXPERIMENTAL

Subjects receive intra-op Ropivicaine 0.5% injection per protocol

Drug: Ropivicaine 0.5%

Interventions

Placebo saline injectionOTHER

20 cc of sterile, injectable saline

Block Negative
Ropivicaine 0.5%DRUG

Ropivicaine

Also known as: Hospiria
Block Positive

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Adult Reconstructive Surgery

Durham, North Carolina, 27710, United States

Location

Related Publications (15)

  • 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. doi: 10.1213/01.ane.0000096186.89230.56.

    PMID: 14980931BACKGROUND

  • 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. doi: 10.1016/s0883-5403(03)00198-0.

    PMID: 12934209BACKGROUND

  • 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. doi: 10.1093/bja/aeh224. Epub 2004 Jul 9.

    PMID: 15247111BACKGROUND

  • 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. doi: 10.1213/00000539-199208000-00020.

    PMID: 1632541BACKGROUND

  • 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.

    PMID: 8837185BACKGROUND

  • 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. doi: 10.1034/j.1399-6576.1999.431009.x.

    PMID: 10593465BACKGROUND

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

    PMID: 9650474BACKGROUND

  • 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. doi: 10.1097/01.blo.0000147701.24029.cc.

    PMID: 15534532BACKGROUND

  • 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. doi: 10.1016/s0883-5403(97)90178-9.

    PMID: 9268795BACKGROUND

  • 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. doi: 10.1055/s-0030-1248181.

    PMID: 16152868BACKGROUND

  • 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. doi: 10.1055/s-0030-1248180.

    PMID: 16152867BACKGROUND

  • 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. doi: 10.1016/j.rapm.2004.11.009.

    PMID: 15765454BACKGROUND

  • 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. doi: 10.1016/j.arth.2004.02.043.

    PMID: 15343531BACKGROUND

  • 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. doi: 10.1054/arth.2001.21496.

    PMID: 11307127BACKGROUND

  • 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. doi: 10.1053/rapm.2002.29253.

    PMID: 11915059BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Michael Bolognesi, MD
Organization
Duke UMC
bolog002@mc.duke.edu
919-668-4732

Study Officials

  • Michael P Bolognesi, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 3, 2015

Results First Posted

May 3, 2013

Record last verified: 2013-03

Locations

US(1)