Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement - Full Text View

Sponsor:	University of Louisville
Collaborator:	EKR Therapeutics, Inc
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00895531

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:

MedlinePlus related topics: Knee Replacement Nausea and Vomiting

Drug Information available for: Morphine sulfate

U.S. FDA Resources

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

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

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:	Anupama Wadhwa, MD, 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:	August 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

Knee Replacement, Total
Morphine

Additional relevant MeSH terms:

Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 24, 2012