Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00895531
First received: May 7, 2009
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Drug: Depodur
Procedure: sciatic nerve block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Peripheral Nerve Blocks vs. Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement: A Prospective, Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time Required for Placement of Block [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Time to first use of rescue analgesia and PCA [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Total opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Degree of knee flexion (Range of motion) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Day of first ambulation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of days required to achieve a 110° knee flexion [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of days of hospitalization [ Time Frame: one week ] [ Designated as safety issue: No ]
  • Need for manipulation of knee joint under general anesthesia [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Secondary effects: nausea and vomiting, pruritus, supplemental oxygen, urinary catheterization [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Satisfaction score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peripheral Nerve group
Group will receive sciatic catheter placed before or after surgery by subgluteal approach with the use of ultrasound. The ischial tuberosity will be identified with the ultrasound probe and its midpoint marked. A catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
Procedure: sciatic nerve block
The sciatic nerve will be identified at the subgluteal level with ultrasound. A point 3 cm lateral and 4 cm caudad will be marked. Patients will be placed in the lateral position. A 18 G Tuohy needle will be inserted at a 45° angle until a peroneal or tibial twitch is obtained at 1.5 mA. Once the current can be reduced to obtain a twitch less than 0.5 mA, a catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
Other Name: Nerve block, sciatic
Experimental: Depodur Group
patients will have an L2-L3 epidural placed while they are in the sitting position before or after femoral catheter placement. They will receive 7.5 mg Depodur via the epidural catheter. All of these patients will receive Singular 10 mg and Claritin 10 mg before the epidural Depodur is placed, as per our protocol of patients receiving EREM.
Drug: Depodur
7.5 mg Depodur via the epidural catheter
Other Name: morphine sulfate extended-release liposome injection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for total knee replacement or revision of total knee replacement
  • Agree to have a regional technique including neuraxial analgesia for post-operative analgesia
  • Be 18 to 70 years old
  • Classified as ASA score I-III

Exclusion Criteria:

  • Allergic to morphine
  • Allergic to local anesthetics
  • Been on opioids for more than 4 weeks
  • Not willing to be randomized
  • On anticoagulation medications that prevent placement of epidural
  • Sensitive to effects of neuraxial opioids
  • BMI>35
  • Severe COPD
  • Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major criteria of the STOP questionnaire and have one of the minor criteria will be excluded from the study

STOP Questionnaire for OSA

Major Criteria:

S- Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?

T—"Do you often feel tired, fatigued, or sleepy during daytime?

O—"Has anyone observed you stop breathing during your sleep?

P—"Do you have or are you being treated for high blood pressure?

Minor Criteria:

  • BMI>35
  • Age>50 yrs
  • Neck Circumference>40 cm
  • Male gender
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895531

Contacts
Contact: Anupama Wadhwa, MD 502-852-1005 anupama.wadhwa@louisville.edu

Locations
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Stephanie Redfern    502-562-3737      
Principal Investigator: Anupama Wadhwa, MD         
Sponsors and Collaborators
University of Louisville
EKR Therapeutics, Inc
Investigators
Principal Investigator: Anupama Wadhwa, MD University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00895531     History of Changes
Other Study ID Numbers: UofL OICN 091095
Study First Received: May 7, 2009
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Knee Replacement, Total
Morphine

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014