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Clinical Trials/NCT04236323
NCT04236323
Completed
Not Applicable

The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control

Seoul National University Hospital1 site in 1 country68 target enrollmentFebruary 14, 2020

Overview

Phase
Not Applicable
Intervention
Not used remifentanil infusion
Conditions
Pain, Postoperative
Sponsor
Seoul National University Hospital
Enrollment
68
Locations
1
Primary Endpoint
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

Detailed Description

The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.

Registry
clinicaltrials.gov
Start Date
February 14, 2020
End Date
January 7, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • ASA class I,II,III
  • Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
  • Age ranges from 20 to 70

Exclusion Criteria

  • Patients who didn't agree to study
  • Patients can't control PCA(Patient-Controlled-Analgesia) independently
  • Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
  • Patients who have severe respiratory disease or hepatic failure
  • Patinets who have known neuropathy or coagulopathy
  • Pregnancy
  • Patients with allegies to the drugs used in this study

Arms & Interventions

not used intraoperative remifentanil infusion

Adult patients aged \< 70 years and ASA class \< III undergoing rotator cuff repair not used intraoperative remifentanil infusion

Intervention: Not used remifentanil infusion

Outcomes

Primary Outcomes

Total infused dose of patient controlled analgesia(PCA) drug during 24 hours

Time Frame: From end of operation to the 24hours after operation

Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia

Secondary Outcomes

  • Total patient's trial to PCA bolus infusion(24 hours after surgery)
  • Numerical Ratings Scale(Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery)
  • Incidence of postoperative nausea and vomiting(24 hours after surgery)

Study Sites (1)

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