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

Arthroplasty, Replacement, Knee research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Arthroplasty, Replacement, Knee

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Depodur7.5 mg Depodur via the epidural catheter

Procedure:sciatic nerve blockThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Peripheral Nerve groupGroup 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.

Depodur Grouppatients 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.

Study Status

Terminated

Start Date: December 2009

Completed Date: December 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Postoperative Pain

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Anupama Wadhwa, MD

Lead Sponsor: University of Louisville

Collaborator: EKR Therapeutics, Inc

More information:https://clinicaltrials.gov/show/NCT00895531

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