Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia

• ClinicalTrials.gov Identifier: NCT03812003
• Recruitment Status: Unknown
• First Posted: January 22, 2019
• Last Update Posted: January 22, 2019
• Sponsor: Tri-Service General Hospital
• Information provided by (Responsible Party): Wei-Hung Chan, Tri-Service General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Opioid-Induced Disorders	Drug: Remifentanil	Phase 4

Detailed Description:

1. After obtaining informed consent, patients will be randomized into two groups.
2. 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.
3. 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
4. group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
5. 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
6. In ward: record the numerical rating scale (NRS) and total analgesics consumption

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Breast cancer patient
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
• Actual Study Start Date: January 11, 2019
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: remifentanil; 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.	Drug: Remifentanil; remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml; Other Name: Remifentanil ALVOGEN powder
No Intervention: no intervention; After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes.

Outcome Measures

Primary Outcome Measures :

1. Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR) [ Time Frame: 0 minutes ]
   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)
2. Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   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)
3. The amount analgesic requirement in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   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 :

1. degree of post-operative nausea in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   Record the degree of nausea in PAR: mild, moderate, severe
2. degree of post-operative vomiting in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   Record the degree of vomiting in PAR: mild, moderate, severe
3. post-operative blood pressure in post-anesthesia room (PAR) [ Time Frame: 0 minutes ]
   Record the blood pressure(mmHg) in PAR
4. post-operative systolic blood pressure in post-anesthesia room (PAR) [ Time Frame: 0 minutes ]
   Record the systolic blood pressure(mmHg) in PAR
5. post-operative systolic blood pressure in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   Record the systolic blood pressure(mmHg) in PAR
6. post-operative diastolic blood pressure in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   Record the diastolic blood pressure(mmHg) in PAR
7. post-operative heart rate in post-anesthesia room (PAR) [ Time Frame: 0 minutes ]
   Record the heart rate (beat/min) in PAR
8. post-operative heart rate in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
   Record the heart rate (beat/min) in PAR
9. post-operative pulse oximeter in post-anesthesia room (PAR) [ Time Frame: 0 minutes ]
   Record the pulse oximeter(SpO2; %) in PAR
10. postoperative pulse oximeter in post-anesthesia room (PAR) [ Time Frame: 30 minutes ]
    Record the pulse oximeter(SpO2; %) in PAR
11. Numerical Rating Score (NRS) for pain score in ward [ Time Frame: 1 hour after transferring to 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)
12. Numerical Rating Score (NRS) for pain score in ward [ Time Frame: 2 hours after transferring to 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)
13. Numerical Rating Score (NRS) for pain score in ward [ Time Frame: 4 hours after transferring to 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)
14. Numerical Rating Score (NRS) for pain score in ward [ Time Frame: 8 hours after transferring to 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)
15. Numerical Rating Score (NRS) for pain score in ward [ Time Frame: 24 hours after transferring to 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)
16. total analgesics requirement in ward [ Time Frame: 24hr after transferring to ward ]
    Record total analgesic requirement (mg) in ward

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: breast cancer female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Wei-Hung Chan, MD; 886-2-78923311 ext 12546; whcken@gmail.com

Contact: Zhi-Fu Wu, MD; 886-2-78923311 ext 12852; aneswu@gmail.com

Locations

Taiwan

Tri-Service General Hospital; Recruiting

Taipei, Taiwan, 114

Contact: Wei-Hung Chan, Doctorate 886-2-87923311 ext 12546 whcken@gmail.com

Principal Investigator: Wei-Hung Chan, Doctorate

Sponsors and Collaborators

Tri-Service General Hospital

Investigators

• Study Chair: Jyh-cherng Yu, MD; Tri-Service General Hospital

More Information

• Responsible Party: Wei-Hung Chan, Principal Investigator, Tri-Service General Hospital
• ClinicalTrials.gov Identifier: NCT03812003
• Other Study ID Numbers: 2-107-05-162
• First Posted: January 22, 2019
• Last Update Posted: January 22, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Numerical rating scale, rescue analgesic amount

• 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

Keywords provided by Wei-Hung Chan, Tri-Service General Hospital:

opioid-induced hyperalgesia, remifentanil

Additional relevant MeSH terms:

Hyperalgesia; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Remifentanil; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents