The Effect of Remifentanil on Rebound Pain

Overview

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.

Full Title of Study: “The Effect of Remifentanil on Rebound Pain in Patients Receiving General Anesthesia for Shoulder Arthroplasty After Brachial Plexus Block for Postoperative Pain Control”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 12, 2020

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.

Interventions

  • Drug: Not used remifentanil infusion
    • Remifentanil is not used during operation

Arms, Groups and Cohorts

  • Experimental: not used intraoperative remifentanil infusion
    • Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not used intraoperative remifentanil infusion
  • No Intervention: used intraoperative remifentanil infusion
    • Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair used intraoperative remifentanil infusion maintaining target concentration of 2-6ng/ml

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Numerical Ratings Scale
    • Time Frame: Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
    • Degree of pain is assessed using Numerical Ratings Scale at 4 hours for 24 hours after operation. The patients choose one of the digits from 0 to 10, the zero-point is painless, and the ten-point means the one with the most severe pain.
  • Total patient’s trial to PCA bolus infusion
    • Time Frame: 24 hours after surgery
    • The total number of times patients press the infusion button on the PCA to control pain
  • Incidence of postoperative nausea and vomiting
    • Time Frame: 24 hours after surgery
    • Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Tae Kim, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jin-Tae Kim, MD., PhD, Principal Investigator, Seoul National University Hospital

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