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

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ClinicalTrials.gov Identifier: NCT00620828
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : May 3, 2013
Last Update Posted : June 3, 2015
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Placebo saline injection Drug: Ropivicaine 0.5% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial
Study Start Date : May 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Block Negative
Subjects receive intra-op saline injection per protocol
Other: Placebo saline injection
20 cc of sterile, injectable saline

Experimental: Block Positive
Subjects receive intra-op Ropivicaine 0.5% injection per protocol
Drug: Ropivicaine 0.5%
Other Name: Hospiria

Primary Outcome Measures :
  1. Numeric Pain Score [ Time Frame: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection ]
    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).

Secondary Outcome Measures :
  1. Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption [ Time Frame: 4 hours to 24 hours post-op ]
    The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.

  2. Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance [ Time Frame: 24 hours post-op ]
    Ambulation distance walked by participants 24-hours post-operatively

  3. Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion [ Time Frame: 24 hours post-op ]
    Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort

  4. Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise [ Time Frame: 4 hours, 8 hours, 12 hours and 24 hours post-op ]
    Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620828

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United States, North Carolina
Duke University Adult Reconstructive Surgery
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Michael P Bolognesi, M.D. Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00620828    
Other Study ID Numbers: Pro00000233
SPS# 139715
First Posted: February 22, 2008    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: June 3, 2015
Last Verified: March 2013
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations