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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00620828
First received: February 12, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Numeric Pain Score [ Time Frame: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection ] [ Designated as safety issue: No ]
    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:
  • Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption [ Time Frame: 4 hours to 24 hours post-op ] [ Designated as safety issue: No ]
    The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.

  • Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]
    Ambulation distance walked by participants 24-hours post-operatively

  • Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion [ Time Frame: 24 hours post-op ] [ Designated as safety issue: No ]
    Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort

  • Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise [ Time Frame: 4 hours, 8 hours, 12 hours and 24 hours post-op ] [ Designated as safety issue: No ]
    Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals


Enrollment: 67
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%
Ropivicaine
Other Name: Hospiria

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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

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

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00620828     History of Changes
Other Study ID Numbers: Pro00000233, SPS# 139715
Study First Received: February 12, 2008
Results First Received: June 17, 2010
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013