The Effect of Remifentanil on Rebound Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236323
• Other study ID #: 1912-041-1087
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: May 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 7, 2021
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total infused dose of patient controlled analgesia(PCA) drug during 24 hours	Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia	From end of operation to the 24hours after operation
Secondary	Numerical Ratings Scale	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.	Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
Secondary	Total patient's trial to PCA bolus infusion	The total number of times patients press the infusion button on the PCA to control pain	24 hours after surgery
Secondary	Incidence of postoperative nausea and vomiting	Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview	24 hours after surgery