The Effect of Remifentanil on Rebound Pain

NCT ID: NCT04236323

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2021-01-07

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

not used intraoperative remifentanil infusion

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

Group Type: EXPERIMENTAL

Not used remifentanil infusion

Intervention Type: DRUG

Remifentanil is not used during operation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Not used remifentanil infusion

Remifentanil is not used during operation

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Tae Kim, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Jin-Tae Kim

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1912-041-1087

Identifier Type: -

Identifier Source: org_study_id