Continuous Femoral and Tibial Nerve Blocks in TKA Patients

NCT ID: NCT01680692

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to evaluate whether a new regional anesthesia technique would provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot drop after knee replacement surgery.

Detailed Description

The aim of this study is to compare and measure the effects of Ropivicaine given through catheters located in the femoral and tibial nerves on indices of sensory blockade after total knee arthroplasties. This is a randomized, prospective study designed to address the primary research question: Does placing a continuous femoral & tibial catheter infusion lead to superior analgesia and patient satisfaction during the entire hospital stay? The secondary research question is: Will selectively placing a continuous tibial catheter decrease the episodes of transient foot drop to zero? Investigators know from own regional institutional practices that by performing a continuous femoral with a single shot sciatic nerve block provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement of continuous catheters in the femoral and tibial nerves would provide better analgesia and lead to no episodes of foot drop as compared to the patients that receive continuous femoral and single shot sciatic blocks.

Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about 95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic) of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic clinic will provide a copy of the consent form to the subject so that they can review it, and if interested in participating in the study, the patient can then contact the Principal Investigator or Study Coordinator directly. After informed consent is obtained, patients will be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1 will receive a pre-operative continuous femoral catheter and a post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be performed under general anesthesia with laryngeal mask airway. Considering the fact that by placing a selective continuous tibial catheter pre-operatively, we run the risk of the catheter being the surgical field during the case. For this reason, it was decided that placement after the procedure would be best. Therefore, the patient will be taken back to the block room post-operatively and a continuous tibial nerve catheter or single shot (depending on what group assigned) will be placed and bolused using the same technique as previously described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required for an observed post-operative pain control difference. In order to achieve a statistically significant result to detect the previously observed difference, a sample of 38 patients in each group (total of 76) would be required. Assuming a high consent rate and given the fact many TKA's it is projected that this study can be completed in approximately 12 months.

Conditions

Analgesia in Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous femoral and single shot sciatic nerve block

Will receive pre-operative continuous femoral catheter \& post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine \& 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.

Group Type: ACTIVE_COMPARATOR

Ropivicaine

Intervention Type: DRUG

Infusion of local anesthetic for post-operative analgesia.

Continuous Femoral Nerve Catheter

Intervention Type: DEVICE

Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.

Continuous femoral and tibial peripheral nerve catheters

Patients will receive pre-operative continuous femoral catheter \& post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) \& 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.

Group Type: EXPERIMENTAL

Ropivicaine

Intervention Type: DRUG

Infusion of local anesthetic for post-operative analgesia.

Continuous Femoral Nerve Catheter

Intervention Type: DEVICE

Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.

Continuous Tibial Nerve Catheter

Intervention Type: DEVICE

Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.

Interventions

Ropivicaine

Infusion of local anesthetic for post-operative analgesia.

Intervention Type: DRUG

Continuous Femoral Nerve Catheter

Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.

Intervention Type: DEVICE

Continuous Tibial Nerve Catheter

Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.

Intervention Type: DEVICE

Other Intervention Names

Continous femoral nerve catheter infusion; Continuous tibial nerve catheter infusion

Eligibility Criteria

Inclusion Criteria

• Adult patients (18-85 years old) undergoing elective total knee arthroplasty's
• American Society of Anesthesiology Classification (ASA) 1, 2, or 3

Exclusion Criteria

• Patient refusal

• Under 18
• Pregnancy
• Presence of neurological disease or existing parasthesia
• Diabetes
• Chronic drug use
• Infection of leg
• American Society of Anesthesiology Classification (ASA) 4-6 (unstable conditions)
• History of allergy to local anesthetics or opioids

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: collaborator

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hana Teissler, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso

John Zaki, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso

Locations

University Medical Center of El Paso, Texas Tech University Health Sciences Center

El Paso, Texas, United States

Countries

United States

Related Links

http://elpaso.ttuhsc.edu/som/anesthesiology/

Related Info

Other Identifiers

E12094

Identifier Type: -

Identifier Source: org_study_id