Treatment Trials

15 Clinical Trials for Various Conditions

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COMPLETED
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Description

IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.

COMPLETED
Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery
Description

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve. The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters. There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.

NOT_YET_RECRUITING
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Description

Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.

COMPLETED
Post-operative Lite Run Study
Description

Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017 based on clinical testing of adults, independent agency testing and in-house evaluations. This will be a combined study with multiple purposes with respect to the evaluation of its use with the post-operative pediatric population. A first purpose is to verify safety and feasibility of the device on pediatric patients. A second purpose is to statistically test the effectiveness of Lite Run to decrease physical burden on the therapist during post-operative gait training for children and adolescents with cerebral palsy as compared to current methods of body weight-supported gait training. A third purpose is to measure and qualitatively evaluate the effectiveness of the device on patient outcomes and improving patient and therapist satisfaction.

RECRUITING
Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Description

This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.

COMPLETED
Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery
Description

The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.

WITHDRAWN
Effects of Dexmedetomidine on Tourniquet Pain Associated With Lower Extremity Surgeries Under General Anesthesia
Description

This study is being done to determine if the drug known as dexmedetomidine improves the way we care for patients when their surgery involves the use of a tourniquet on the leg. A tourniquet is sometimes used for lower leg or foot surgery to decrease the blood loss for the patient and to make it easier for the surgeon to do his work.

COMPLETED
SFDI in High Energy Lower Extremity Fracture
Description

This is a non-randomized prospective study of 20 patients with high energy lower extremity fractures evaluating feasibility and acceptability of SFDI, a real-time optical imaging technology.

Conditions
COMPLETED
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
Description

This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.

Conditions
COMPLETED
Improving Recovery After Orthopaedic Trauma: Cognitive-Behavioral Based Physical Therapy (CBPT)
Description

The goal of the CBPT study is to determine the efficacy of the CBPT program for improving outcomes in service members and civilians at-risk for poor outcomes following traumatic lower-extremity injury. Primary outcome is physical function measured through a patient-reported questionnaire and physical performance tests. Secondary outcomes include pain and general health. Tertiary outcome is return to work/duty.

COMPLETED
A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery
Description

One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.

UNKNOWN
Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery
Description

The purpose of this study is to compare injecting local anesthetic (numbing medication) in different patterns around a major nerve in the leg. Patients who undergo surgery to the lower leg and/or foot are usually offered the option of a nerve block to help with pain control after surgery. A nerve block involves injecting local anesthetic (numbing medicine) by a nerve or nerves that provide sensation to the area where surgery will be performed. The local anesthetic (numbing medication) numbs up the area where the surgery is performed and helps decrease the amount of pain felt after surgery. The local anesthetic (numbing medication) can be injected in various patterns by a nerve, such as in one spot by a nerve or completely surrounding a nerve. The local anesthetic will be either injected around the sciatic nerve or will injected in a way that will split the sciatic nerve into the two component nerves that make it up, the tibial and sciatic, and surrounds each nerve. The hypothesis is that subjects in the group that local anesthetic is injected in a pattern that separates the sciatic nerve into the two component nerves may have a faster onset time of regional anesthesia and block success than subjects in the group that have the local anesthetic injected at around the nerve.

COMPLETED
Virtual Reality for Pain in Acute Orthopedic Injuries
Description

The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.

COMPLETED
Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks
Description

This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.

RECRUITING
Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery
Description

The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.