NCT02043366

Brief Summary

Purpose: To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a combination of both received before anesthesia induction. To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 28, 2015

Completed
Last Updated

January 8, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

January 15, 2014

Results QC Date

August 27, 2015

Last Update Submit

December 8, 2015

Conditions

PainAnesthesia

Keywords

RemifentanilOpioid-induced hyperalgesiaPostoperative painPain Intensity

Outcome Measures

Primary Outcomes (1)

  • Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm

    The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively

    24 hours after surgery

Secondary Outcomes (6)

  • Pain Score (NRS)

    3h, 6h, 12h, and 24h after surgery

  • Time of First Postoperative Analgesic Requirement

    1 hour post surgery

  • Occurrence of Side Effects

    24 hours

  • Total Dose of First Postoperative Analgesic Requirement

    1 hour after surgery

  • Cumulative Sufentanyl Consumption

    24 hours

  • +1 more secondary outcomes

Study Arms (6)

Normal Saline

PLACEBO COMPARATOR

Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Normal SalineDrug: Remifentanil

Butorphanol

ACTIVE COMPARATOR

Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil

Drug: ButorphanolDrug: Remifentanil

Flurbiprofen axetilⅠ

ACTIVE COMPARATOR

Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil

Drug: Flurbiprofen axetilDrug: Remifentanil

Flurbiprofen axetilⅡ

ACTIVE COMPARATOR

Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil

Drug: Flurbiprofen axetilDrug: Remifentanil

Butorphanol-Flurbiprofen axetil

ACTIVE COMPARATOR

A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil

Drug: ButorphanolDrug: Flurbiprofen axetilDrug: Remifentanil

Sufentanil

SHAM COMPARATOR

Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil

Drug: Normal SalineDrug: Sufentanil

Interventions

Normal SalineDRUG

Normal Saline is intravenously administrated before anesthesia induction

Normal SalineSufentanil
ButorphanolDRUG

Butorphanol is intravenously administrated

ButorphanolButorphanol-Flurbiprofen axetil
Flurbiprofen axetilDRUG

Flurbiprofen axetil is intravenously administrated

Butorphanol-Flurbiprofen axetilFlurbiprofen axetilⅠFlurbiprofen axetilⅡ
RemifentanilDRUG

Remifentanil is intravenously administrated

ButorphanolButorphanol-Flurbiprofen axetilFlurbiprofen axetilⅠFlurbiprofen axetilⅡNormal Saline
SufentanilDRUG

Sufentanil is intravenously administrated

Sufentanil

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is scheduled to undergo lower abdominal surgery under a short general anesthesia of less than 2 hours
  • Subject's American Society of Anesthesiologists physical status is I-II.
  • The subject's parent/legally authorized guardian has given written informed consent to participate.

You may not qualify if:

  • Subject has a diagnosis of renal or liver failure.
  • Subject has a diagnosis of Insulin dependent diabetes.
  • Subject is allergy and contraindication to butorphanol or NSAIDs.
  • Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
  • Subject has any contraindication for the use of patient-controlled analgesia (PCA).
  • Subject is pregnant or breast-feeding.
  • Subject is obese (body mass index \>30kg/m\^2).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (1)

  • Zhang L, Shu R, Zhao Q, Li Y, Yu Y, Wang G. Preoperative butorphanol and flurbiprofen axetil therapy attenuates remifentanil-induced hyperalgesia after laparoscopic gynaecological surgery: a randomized double-blind controlled trial. Br J Anaesth. 2016 Oct;117(4):504-511. doi: 10.1093/bja/aew248. Epub 2016 Oct 17.

    PMID: 28077539DERIVED

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Saline SolutionButorphanolflurbiprofen axetilRemifentanilSufentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingFentanyl

Results Point of Contact

Title
Dr. Guolin Wang
Organization
Tianjin Medical University General Hospital
wangguolinghad@hotmail.com
+8615822855556

Study Officials

  • Guolin Wang, MD

    Tianjin Medical University General Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 23, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

January 8, 2016

Results First Posted

September 28, 2015

Record last verified: 2015-12

Locations

CN(1)