The Effect of Remifentanil on Rebound Pain

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04236323
Collaborator
(none)
68
1
2
10.8
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Not used remifentanil infusion
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 14, 2020
Actual Primary Completion Date :
Aug 12, 2020
Actual Study Completion Date :
Jan 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: not used intraoperative remifentanil infusion

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jin-Tae Kim Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, MD., PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04236323
Other Study ID Numbers:
  • 1912-041-1087
First Posted:
Jan 22, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2021