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

NCT03812003 | Completed Phase 4 DMC

• 1 other identifier: 2-107-05-162
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Induced Disorders

Keywords

opioid-induced hyperalgesia, remifentanil

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (16)

• degree of post-operative nausea in post-anesthesia room (PAR)

  30 minutes

• degree of post-operative vomiting in post-anesthesia room (PAR)

  30 minutes

• post-operative blood pressure in post-anesthesia room (PAR)

  0 minutes

• post-operative systolic blood pressure in post-anesthesia room (PAR)

  0 minutes

• post-operative systolic blood pressure in post-anesthesia room (PAR)

  30 minutes

Study Arms (2)

remifentanil

EXPERIMENTAL

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

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.

Interventions

Remifentanil DRUG

remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml

Also known as: Remifentanil ALVOGEN powder

remifentanil

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: breast cancer female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jyh-cherng Yu, MD

  Tri-Service General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Breast cancer patient

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 22, 2019
• Study Start: January 11, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TW (1)