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

Up-down Sequential Allocation Study to Determine the Optimal Volume, Rate, and Interval of Bolus of Ropivacaine 0.2% in Interscalene Continuous Nerve Catheters for Shoulder Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Ropivacaine

Detailed Description

The purpose of this study is to determine the ideal delivery of local anesthetics for postoperative analgesia when using continuous interscalene peripheral nerve catheters for shoulder surgery. New technology has emerged with electronic pumps that permit intermittent mandatory boluses of local anesthetic to be delivered in addition to continuous infusions. The pump would automatically deliver a bolus at a given interval, but would otherwise be idle for a period of time. This technology could improve the efficacy of local anesthetics, and thereby improve postoperative analgesia.

Continuous peripheral nerve catheters have been shown to improve pain control in several orthopedic surgical procedures when compared to opioids. However, it is not uncommon for patients to experience breakthrough pain in spite of a functional peripheral nerve block. Many times, this breakthrough pain can be managed with a bolus of local anesthetic administered by an anesthesia provider. Until recently, the vast majority of peripheral nerve catheter infusion pumps have only had the capability of providing a constant rate of local anesthetic administration. Newer technology allows for infusion pumps to deliver intermittent mandatory boluses of local anesthetic. This technique of local anesthetic administration has previously been evaluated with popliteal nerve blocks, but to our knowledge has never been evaluated for use with interscalene nerve catheters.

Currently, data would support the idea that a bolus of local anesthetic can improve analgesia with decreased side effects compared to a continuous infusion. However, there is little data evaluating the optimal volume of bolus, the optimal speed of delivery, or the optimal interval between local anesthetic boluses.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volume of bolus; 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; Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.; Other Names: Naropin
Experimental: Rate of delivery of bolus; 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; Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.; Other Names: Naropin
Experimental: Interval between bolus; 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; Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter	Up-down sequential allocation alteration of rate to determine optimal rate of bolus	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Interval of Ropivacaine 0.2% administration of bolus via interscalene catheter	Up-down sequential allocation alteration of interval to determine optimal interval of bolus	1 day

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Joshua R Dooley, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): February 21, 2017
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Pro00072762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No