A Phase 4 interventional study of Ropivacaine in Pain, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Duke University · Phase 4, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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
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
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.
Also known as: Naropin
Optimal Volume of Ropivacaine 0.2% bolus via interscalene catheter
Up-down sequential allocation alteration of volume to determine optimal volume of bolus
Time frame: 1 day
Optimal Rate of Ropivacaine 0.2% administration bolus via interscalene cathter
Up-down sequential allocation alteration of rate to determine optimal rate of bolus
Time frame: 1 day
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
Time frame: 1 day
Plan to share: No
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