Trial · NCT02043366

Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients

NCT02043366, Not applicable, Completed, Tianjin Medical University General Hospital; results first posted 2015-09-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients. Trials, record NCT02043366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02043366

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients
NCT number: NCT02043366
Status: Completed
Phases: Not applicable
Enrollment: 180 participants, actual
Lead sponsor: Tianjin Medical University General Hospital
Conditions: Pain, Anesthesia
Interventions: Normal Saline, Butorphanol, Flurbiprofen axetil, Remifentanil, Sufentanil
First posted: 2014-01-23
Last updated: 2016-01-08
Results first posted: 2015-09-28

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	24 hours after surgery	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
Secondary	Pain Score (NRS)	3h, 6h, 12h, and 24h after surgery	The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Secondary	Time of First Postoperative Analgesic Requirement	1 hour post surgery	First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Secondary	Occurrence of Side Effects	24 hours	Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Secondary	Total Dose of First Postoperative Analgesic Requirement	1 hour after surgery	First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Secondary	Cumulative Sufentanyl Consumption	24 hours	Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively
Secondary	Normalized Area of Hyperalgesia Around the Incision	24 hours after surgery	The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	24 hours after surgery	g	MEAN
SECONDARY	Pain Score (NRS)	3h, 6h, 12h, and 24h after surgery
SECONDARY	Time of First Postoperative Analgesic Requirement	1 hour post surgery
SECONDARY	Occurrence of Side Effects	24 hours
SECONDARY	Total Dose of First Postoperative Analgesic Requirement	1 hour after surgery
SECONDARY	Cumulative Sufentanyl Consumption	24 hours
SECONDARY	Normalized Area of Hyperalgesia Around the Incision	24 hours after surgery	cm^2	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Normal Saline	60.57	Standard Deviation 22.55	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Flurbiprofen AxetilⅠ	78.29	Standard Deviation 24.76	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Flurbiprofen AxetilⅡ	68.50	Standard Deviation 21.98	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Butorphanol	79.7	Standard Deviation 20.93	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Butorphanol-Flurbiprofen Axetil	81.64	Standard Deviation 20.40	g
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm	Sufentanil	89.5	Standard Deviation 23.4	g
Normalized Area of Hyperalgesia Around the Incision	Normal Saline	60.46	Standard Deviation 9.98	cm^2
Normalized Area of Hyperalgesia Around the Incision	Flurbiprofen AxetilⅠ	53.64	Standard Deviation 8.63	cm^2
Normalized Area of Hyperalgesia Around the Incision	Flurbiprofen AxetilⅡ	56.57	Standard Deviation 8.98	cm^2
Normalized Area of Hyperalgesia Around the Incision	Butorphanol	54.00	Standard Deviation 9.30	cm^2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Normal Saline	30
Overall Study	STARTED	Flurbiprofen AxetilⅠ	30
Overall Study	STARTED	Flurbiprofen AxetilⅡ	30
Overall Study	STARTED	Butorphanol	30
Overall Study	STARTED	Butorphanol-Flurbiprofen Axetil	30
Overall Study	STARTED	Sufentanil	30
Overall Study	COMPLETED	Normal Saline	28
Overall Study	COMPLETED	Flurbiprofen AxetilⅠ	28
Overall Study	COMPLETED	Flurbiprofen AxetilⅡ	28
Overall Study	COMPLETED	Butorphanol	28

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Normal Saline
Total, all-cause mortality	Flurbiprofen AxetilⅠ
Total, all-cause mortality	Flurbiprofen AxetilⅡ
Total, all-cause mortality	Butorphanol
Total, all-cause mortality	Butorphanol-Flurbiprofen Axetil
Total, all-cause mortality	Sufentanil
Total, other adverse events	Normal Saline	0	28
Total, other adverse events	Flurbiprofen AxetilⅠ	0	28
Total, other adverse events	Flurbiprofen AxetilⅡ	0	28
Total, other adverse events	Butorphanol	0	28

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28077539	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02043366

GET https://conductscience.org/api/trials/v1/NCT02043366/registered

API reference For AI assistants