Clinical trial NCT03812003: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Opioid-Induced Disorders
Keywords: opioid-induced hyperalgesia, remifentanil
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Breast cancer patient
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
timeFrame: 0 minutes
measure: Numerical Rating Score (NRS) for pain score in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: The amount analgesic requirement in post-anesthesia room (PAR)
timeFrame: 30 minutes
Secondary outcomes:
measure: degree of post-operative nausea in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: degree of post-operative vomiting in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: post-operative blood pressure in post-anesthesia room (PAR)
timeFrame: 0 minutes
measure: post-operative systolic blood pressure in post-anesthesia room (PAR)
timeFrame: 0 minutes
measure: post-operative systolic blood pressure in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: post-operative diastolic blood pressure in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: post-operative heart rate in post-anesthesia room (PAR)
timeFrame: 0 minutes
measure: post-operative heart rate in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: post-operative pulse oximeter in post-anesthesia room (PAR)
timeFrame: 0 minutes
measure: postoperative pulse oximeter in post-anesthesia room (PAR)
timeFrame: 30 minutes
measure: Numerical Rating Score (NRS) for pain score in ward
timeFrame: 1 hour after transferring to ward
measure: Numerical Rating Score (NRS) for pain score in ward
timeFrame: 2 hours after transferring to ward
measure: Numerical Rating Score (NRS) for pain score in ward
timeFrame: 4 hours after transferring to ward
measure: Numerical Rating Score (NRS) for pain score in ward
timeFrame: 8 hours after transferring to ward
measure: Numerical Rating Score (NRS) for pain score in ward
timeFrame: 24 hours after transferring to ward
measure: total analgesics requirement in ward
timeFrame: 24hr after transferring to ward
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Jyh-cherng Yu, MD
role: STUDY_CHAIR
References: