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Clinical Trials/NCT03230565
NCT03230565
Recruiting
Phase 4

A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion

Stanford University1 site in 1 country240 target enrollmentJune 1, 2018

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Surgical Procedure, Unspecified
Sponsor
Stanford University
Enrollment
240
Locations
1
Primary Endpoint
Post-surgical pain
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

The goal of the study is to compare continuous infusions and scheduled bolus infusions for peripheral nerve blocks and their effect on post-surgical pain.

Detailed Description

Regional anesthetic techniques are an integral part to many anesthetic approaches, providing both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia peripheral nerve blocks have been shown to reduce postoperative pain and improve measures such as opioid requirements and readiness for discharge. By using a catheter technique for continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2 and 3, further extending these benefits. Historically these catheters have implemented a continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many institutions have implemented this new protocol for catheter dosing. The beneficial effect of scheduled bolus dosing has not been studied in all blocks and all surgical procedures. The study will consist of three independent arms, each designed to evaluate a different nerve block site: interscalene, adductor canal, and infraclavicular. A total of 60 patients will be enrolled in each arm.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Louis Horn

Professor of Anesthesiology

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Adult patients presenting for nerve block catheters for post-operative analgesia
  • ASA physical status I, II, or III.

Exclusion Criteria

  • Pregnancy
  • Incarceration
  • Pre-operative opioid use \>30 mg morphine equivalents per day
  • Inability to communicate with investigators by telephone
  • Pre-existing neuropathy of the operative extremity.

Arms & Interventions

Continuous Infusion

Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.

Intervention: Ropivacaine

Intermittent Bolus Infusion

Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Post-surgical pain

Time Frame: Post-operative day 0, 1, and 2

Pain scores will be collected using a Numeric Rating Scale (NRS) from 0-10, where 0 is the lowest and 10 is the highest pain level.

Secondary Outcomes

  • Opioid consumption(Post-operative day 0, 1, and 2)
  • Local anesthetic use(Post-operative day 1 and 2)
  • Quality of recovery(Post-operative day 1 and 2)
  • Evidence of diaphragmatic paralysis(Post-operative day 1 and 2)
  • Patient satisfaction(Post-operative day 1 and 2)

Study Sites (1)

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