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

NCT02946268 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00072762
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter

  Up-down sequential allocation alteration of volume to determine optimal volume of bolus

  1 day

Secondary Outcomes (1)

• Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter

  1 day

Other Outcomes (1)

• Optimal Interval of Ropivacaine 0.2% administration of bolus via interscalene catheter

  1 day

Study Arms (3)

Volume of bolus

EXPERIMENTAL

Ropivacaine 0.2% volume increased or decreased by 1ml based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient, the current patient will receive an increase in volume of bolus by 1ml. If pain is less than 5/10 in the previous patient the current patient will receive a decrease in volume by 1ml.

Drug: Ropivacaine

Rate of delivery of bolus

EXPERIMENTAL

Ropivacaine 0.2% rate increased or decreased by 50ml/hr based on previous patient experience. If pain greater than or equal to 5/10 in the previous patient at 30 minutes, the current patient will receive an increase in rate of bolus by 50ml/hr. If the pain is less than 5/10 the rate will be decreased by 50ml/hr.

Drug: Ropivacaine

Interval between bolus

EXPERIMENTAL

Ropivacaine 0.2% interval increased or decreased by 1 hour based on previous patient experience. If the previous patient received pain score of 2/10 at 2 hours then the current patient will have an interval of three hours. If the pain is greater than 2/10, the interval will be shortened by 1 hour.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.

Also known as: Naropin

Interval between bolus; Rate of delivery of bolus; Volume of bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Ambulatory Surgery Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Joshua R Dooley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 27, 2016
• Study Start: February 21, 2017
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: November 13, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)