The Effect of Remifentanil on Rebound Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Not used remifentanil infusion

• Registration Number: NCT04236323
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-19
• Study First Posted: 2020-01-22
• Study Start: 2020-02-14
• Primary Completion: 2020-08-12
• Study Completion: 2021-01-07
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours	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 Outcome Measures

Name	Time	Method
Total patient's trial to PCA bolus infusion	24 hours after surgery	The total number of times patients press the infusion button on the PCA to control pain
Numerical Ratings Scale	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.
Incidence of postoperative nausea and vomiting	24 hours after surgery	Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of