This trial is active, not recruiting.

Condition elective knee surgery
Treatment infinitiplus (tm) needle system
Sponsor The Cleveland Clinic
Start date March 2014
End date January 2017
Trial size 134 participants
Trial identifier NCT02080481, 13-1299


An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety.

This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle.

Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
ultrasound guidance with the InfinitiPlusTM needle guidance system
infinitiplus (tm) needle system
(No Intervention)
ultrasound guidance with a conventional block needle

Primary Outcomes

Time spent in performing ultrasound guided femoral nerve blocks with InfinitiPlusTM needle guidance system
time frame: Day of surgery

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Men or women 18-85 years old - Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter - Written informed consent Exclusion Criteria: - Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics - Pregnancy - Preexisting neuropathy involving the surgical limb

Additional Information

Official title Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia
Principal investigator Alparslan Turan
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.