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

Opioid-Induced Disorders Clinical Trial

Official title:

Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812003
• Other study ID #: 2-107-05-162
• Status: Recruiting
• Phase: Phase 4
• Start date: January 11, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Tri-Service General Hospital
• Contact: Wei-Hung Chan, MD
• Phone: 886-2-78923311
• Email: whcken[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperalgesia
• Opioid-Induced Disorders

Intervention

Drug:
• Remifentanil
remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	0 minutes
Primary	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)	30 minutes
Primary	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	30 minutes
Secondary	degree of post-operative nausea in post-anesthesia room (PAR)	Record the degree of nausea in PAR: mild, moderate, severe	30 minutes
Secondary	degree of post-operative vomiting in post-anesthesia room (PAR)	Record the degree of vomiting in PAR: mild, moderate, severe	30 minutes
Secondary	post-operative blood pressure in post-anesthesia room (PAR)	Record the blood pressure(mmHg) in PAR	0 minutes
Secondary	post-operative systolic blood pressure in post-anesthesia room (PAR)	Record the systolic blood pressure(mmHg) in PAR	0 minutes
Secondary	post-operative systolic blood pressure in post-anesthesia room (PAR)	Record the systolic blood pressure(mmHg) in PAR	30 minutes
Secondary	post-operative diastolic blood pressure in post-anesthesia room (PAR)	Record the diastolic blood pressure(mmHg) in PAR	30 minutes
Secondary	post-operative heart rate in post-anesthesia room (PAR)	Record the heart rate (beat/min) in PAR	0 minutes
Secondary	post-operative heart rate in post-anesthesia room (PAR)	Record the heart rate (beat/min) in PAR	30 minutes
Secondary	post-operative pulse oximeter in post-anesthesia room (PAR)	Record the pulse oximeter(SpO2; %) in PAR	0 minutes
Secondary	postoperative pulse oximeter in post-anesthesia room (PAR)	Record the pulse oximeter(SpO2; %) in PAR	30 minutes
Secondary	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)	1 hour after transferring to ward
Secondary	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)	2 hours after transferring to ward
Secondary	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)	4 hours after transferring to ward
Secondary	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)	8 hours after transferring to ward
Secondary	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)	24 hours after transferring to ward
Secondary	total analgesics requirement in ward	Record total analgesic requirement (mg) in ward	24hr after transferring to ward