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The Effect of Remifentanil on Rebound Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Not used remifentanil infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring hyperalgesia, brachial plexus block, remifentanil

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jin-Tae Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

not used intraoperative remifentanil infusion

used intraoperative remifentanil infusion

Arm Description

Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2020
Last Updated
May 28, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04236323
Brief Title
The Effect of Remifentanil on Rebound Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
January 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
hyperalgesia, brachial plexus block, remifentanil

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
not used intraoperative remifentanil infusion
Arm Type
Experimental
Arm Description
Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair not used intraoperative remifentanil infusion
Arm Title
used intraoperative remifentanil infusion
Arm Type
No Intervention
Arm Description
Adult patients aged < 70 years and ASA class < III undergoing rotator cuff repair used intraoperative remifentanil infusion maintaining target concentration of 2-6ng/ml
Intervention Type
Drug
Intervention Name(s)
Not used remifentanil infusion
Intervention Description
Remifentanil is not used during operation
Primary Outcome Measure Information:
Title
Total infused dose of patient controlled analgesia(PCA) drug during 24 hours
Description
Total infused dose of patient controlled analgesia(PCA) drug during first 24 hours after rotor cuff repair under general anesthesia
Time Frame
From end of operation to the 24hours after operation
Secondary Outcome Measure Information:
Title
Numerical Ratings Scale
Description
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.
Time Frame
Pain levels are checked using Numerical Ratings Scale at 4 hour intervals for 24 hours after surgery
Title
Total patient's trial to PCA bolus infusion
Description
The total number of times patients press the infusion button on the PCA to control pain
Time Frame
24 hours after surgery
Title
Incidence of postoperative nausea and vomiting
Description
Postoperative nausea and vomiting is assessed at 24hr after surgery by a face-to face interview
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Remifentanil on Rebound Pain

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