The Effect of Remifentanil on Rebound Pain

NCT04236323 | Completed

• 1 other identifier: 1912-041-1087
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

hyperalgesia; brachial plexus block; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numerical Ratings Scale

  Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery

• Total patient's trial to PCA bolus infusion

  24 hours after surgery

• Incidence of postoperative nausea and vomiting

  24 hours after surgery

Study Arms (2)

not used intraoperative remifentanil infusion

EXPERIMENTAL

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

Drug: Not used remifentanil infusion

used intraoperative remifentanil infusion

NO INTERVENTION

Adult patients aged \< 70 years and ASA class \< III undergoing rotator cuff repair used intraoperative remifentanil infusion maintaining target concentration of 2-6ng/ml

Interventions

Not used remifentanil infusion DRUG

Remifentanil is not used during operation

not used intraoperative remifentanil infusion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Jin-Tae Kim, MD., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 22, 2020
• Study Start: February 14, 2020
• Primary Completion: August 12, 2020
• Study Completion: January 7, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)