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

NCT00895531 | Terminated Phase 4 Results

• 1 other identifier: 09.0255
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Knee Replacement, Total; Morphine

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Pain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).

  48 hours

Study Arms (2)

Peripheral Nerve group

ACTIVE COMPARATOR

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

Depodur Group

EXPERIMENTAL

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

Interventions

Depodur DRUG

7.5 mg Depodur via the epidural catheter

Also known as: morphine sulfate extended-release liposome injection

Depodur Group

sciatic nerve block PROCEDURE

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.

Also known as: Nerve block, sciatic

Peripheral Nerve group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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?

Sponsors & Collaborators

• University of Louisville: lead
• EKR Therapeutics, Inc: collaborator

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Nancy Alsip
• Organization: University Louisville

nlalsi01@exchange.louisville.edu

502-852-2905

Study Officials

• Anupama Wadhwa, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

US (1)