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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02946268
• Other study ID #: Pro00072762
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 21, 2017
• Est. completion date: February 21, 2017

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 21, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ropivacaine
Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.

Locations

Country	Name	City	State
United States	Duke Ambulatory Surgery Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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