Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
Primary Purpose
Opioid-Induced Disorders
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional prevention trial for Opioid-Induced Disorders focused on measuring opioid-induced hyperalgesia, remifentanil
Eligibility Criteria
Inclusion Criteria:
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
- Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)
Exclusion Criteria:
- Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
- Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
- Subject has psychiatric disease
- allergic to opioid or propofol
- History of alcoholism
- History of drug abuse
Sites / Locations
- Tri-Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
remifentanil
no intervention
Arm Description
After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes.
After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes.
Outcomes
Primary Outcome Measures
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
The amount analgesic requirement in post-anesthesia room (PAR)
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR
Secondary Outcome Measures
degree of post-operative nausea in post-anesthesia room (PAR)
Record the degree of nausea in PAR: mild, moderate, severe
degree of post-operative vomiting in post-anesthesia room (PAR)
Record the degree of vomiting in PAR: mild, moderate, severe
post-operative blood pressure in post-anesthesia room (PAR)
Record the blood pressure(mmHg) in PAR
post-operative systolic blood pressure in post-anesthesia room (PAR)
Record the systolic blood pressure(mmHg) in PAR
post-operative systolic blood pressure in post-anesthesia room (PAR)
Record the systolic blood pressure(mmHg) in PAR
post-operative diastolic blood pressure in post-anesthesia room (PAR)
Record the diastolic blood pressure(mmHg) in PAR
post-operative heart rate in post-anesthesia room (PAR)
Record the heart rate (beat/min) in PAR
post-operative heart rate in post-anesthesia room (PAR)
Record the heart rate (beat/min) in PAR
post-operative pulse oximeter in post-anesthesia room (PAR)
Record the pulse oximeter(SpO2; %) in PAR
postoperative pulse oximeter in post-anesthesia room (PAR)
Record the pulse oximeter(SpO2; %) in PAR
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Numerical Rating Score (NRS) for pain score in ward
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
total analgesics requirement in ward
Record total analgesic requirement (mg) in ward
Full Information
NCT ID
NCT03812003
First Posted
January 13, 2019
Last Updated
January 18, 2019
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03812003
Brief Title
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
Official Title
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.
Detailed Description
After obtaining informed consent, patients will be randomized into two groups.
All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
In ward: record the numerical rating scale (NRS) and total analgesics consumption
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Disorders
Keywords
opioid-induced hyperalgesia, remifentanil
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Breast cancer patient
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remifentanil
Arm Type
Experimental
Arm Description
After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes.
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Remifentanil ALVOGEN powder
Intervention Description
remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml
Primary Outcome Measure Information:
Title
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
Description
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
0 minutes
Title
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
Description
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by Numerical Rating Scale (Numerical Rating Scale)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
30 minutes
Title
The amount analgesic requirement in post-anesthesia room (PAR)
Description
1.The pain after breast surgery is moderate and suppose to be reduced after combined prescription of NSAID and local analgesics during surgery. Post-operative pain is supposed to be related with hyperalgesia. 2.Record the degree of post-operative pain by record additional analgesics amount (rescue medication, mg) in PAR
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
degree of post-operative nausea in post-anesthesia room (PAR)
Description
Record the degree of nausea in PAR: mild, moderate, severe
Time Frame
30 minutes
Title
degree of post-operative vomiting in post-anesthesia room (PAR)
Description
Record the degree of vomiting in PAR: mild, moderate, severe
Time Frame
30 minutes
Title
post-operative blood pressure in post-anesthesia room (PAR)
Description
Record the blood pressure(mmHg) in PAR
Time Frame
0 minutes
Title
post-operative systolic blood pressure in post-anesthesia room (PAR)
Description
Record the systolic blood pressure(mmHg) in PAR
Time Frame
0 minutes
Title
post-operative systolic blood pressure in post-anesthesia room (PAR)
Description
Record the systolic blood pressure(mmHg) in PAR
Time Frame
30 minutes
Title
post-operative diastolic blood pressure in post-anesthesia room (PAR)
Description
Record the diastolic blood pressure(mmHg) in PAR
Time Frame
30 minutes
Title
post-operative heart rate in post-anesthesia room (PAR)
Description
Record the heart rate (beat/min) in PAR
Time Frame
0 minutes
Title
post-operative heart rate in post-anesthesia room (PAR)
Description
Record the heart rate (beat/min) in PAR
Time Frame
30 minutes
Title
post-operative pulse oximeter in post-anesthesia room (PAR)
Description
Record the pulse oximeter(SpO2; %) in PAR
Time Frame
0 minutes
Title
postoperative pulse oximeter in post-anesthesia room (PAR)
Description
Record the pulse oximeter(SpO2; %) in PAR
Time Frame
30 minutes
Title
Numerical Rating Score (NRS) for pain score in ward
Description
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
1 hour after transferring to ward
Title
Numerical Rating Score (NRS) for pain score in ward
Description
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
2 hours after transferring to ward
Title
Numerical Rating Score (NRS) for pain score in ward
Description
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
4 hours after transferring to ward
Title
Numerical Rating Score (NRS) for pain score in ward
Description
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
8 hours after transferring to ward
Title
Numerical Rating Score (NRS) for pain score in ward
Description
Record the degree of post-operative pain by Numerical Rating Scale (NRS)(0-10; 0= no pain; 10=pain as bad as can be)
Time Frame
24 hours after transferring to ward
Title
total analgesics requirement in ward
Description
Record total analgesic requirement (mg) in ward
Time Frame
24hr after transferring to ward
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
breast cancer female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)
Exclusion Criteria:
Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
Subject has psychiatric disease
allergic to opioid or propofol
History of alcoholism
History of drug abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Hung Chan, MD
Phone
886-2-78923311
Ext
12546
Email
whcken@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Fu Wu, MD
Phone
886-2-78923311
Ext
12852
Email
aneswu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-cherng Yu, MD
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Hung Chan, Doctorate
Phone
886-2-87923311
Ext
12546
Email
whcken@gmail.com
First Name & Middle Initial & Last Name & Degree
Wei-Hung Chan, Doctorate
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Numerical rating scale, rescue analgesic amount
Learn more about this trial
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
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