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

Phase 4

• Conditions: Opioid-Induced Disorders
• Interventions: Drug: Remifentanil

• Registration Number: NCT03812003
• Lead Sponsor: Tri-Service General Hospital

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

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 Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-11
• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-18
• Last Update Submitted: 2019-01-18
• Study First Posted: 2019-01-22
• Last Update Posted: 2019-01-22
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil	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.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)	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)
The amount analgesic requirement in post-anesthesia room (PAR)	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

Name	Time	Method
post-operative pulse oximeter in post-anesthesia room (PAR)	0 minutes	Record the pulse oximeter(SpO2; %) in PAR
postoperative pulse oximeter in post-anesthesia room (PAR)	30 minutes	Record the pulse oximeter(SpO2; %) in PAR
degree of post-operative nausea in post-anesthesia room (PAR)	30 minutes	Record the degree of nausea in PAR: mild, moderate, severe
degree of post-operative vomiting in post-anesthesia room (PAR)	30 minutes	Record the degree of vomiting in PAR: mild, moderate, severe
post-operative blood pressure in post-anesthesia room (PAR)	0 minutes	Record the blood pressure(mmHg) in PAR
post-operative systolic blood pressure in post-anesthesia room (PAR)	30 minutes	Record the systolic blood pressure(mmHg) in PAR
post-operative diastolic blood pressure in post-anesthesia room (PAR)	30 minutes	Record the diastolic blood pressure(mmHg) in PAR
post-operative heart rate in post-anesthesia room (PAR)	30 minutes	Record the heart rate (beat/min) in PAR
Numerical Rating Score (NRS) for pain score in ward	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)
total analgesics requirement in ward	24hr after transferring to ward	Record total analgesic requirement (mg) in ward

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan