Optimal Volume, Rate, and Interval of Bolus Nerve Catheters for Shoulder Surgery

• Status: Withdrawn
• Trial end date: 2017-02-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the ideal delivery of local anesthetics for pain control when using continuous interscalene peripheral nerve catheters for shoulder surgery.

The study will be conducted in three stages. In the first stage the ideal bolus volume of ropivacaine will be determined. In the second stage the optimal rate of delivery of the bolus (infusion rate) will be determined. Finally, once both the ideal volume and infusion rate has been determined, the optimal interval between boluses of local anesthetic will be determined.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Male or female, ≥18 years of age

• Patients scheduled to undergo unilateral shoulder surgery at Duke University Medical Center, including arthroscopic rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement.

• American Society of Anesthesiology (ASA) Physical Class 1-3.

• BMI ≤40 kg/m2

Exclusion Criteria:

• Patients with a contraindication to placement of interscalene nerve block. This includes abnormal clotting, skin infection involving the neck, the presence of neurological disorders or cervical spine disease, contralateral phrenic nerve dysfunction, or moderate-severe COPD (FEV1<80% of normal values and/or FEV1/FVC < 0.70)

• Patients with chronic pain (pain existing for longer than 6 months), or taking chronic opioids (greater than 60 morphine equivalents per day) at time of surgery

• Contraindications to or known drug interactions with local anesthetics

• Patients who will be discharged home directly from PACU

• Planned administration of another investigational product or procedure during the subject's participation in this study.

• Patients who do not have the capacity to give legally effective consent

• Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.

• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.

• Pregnant women