UMIN-CTR Clinical Trial

Public title

Addition of epinephrine spoils anti-pruritic effect of butorphanol against epidural morphine

Acronym

Co-use of epinephrine and butorphanol

Scientific Title

Addition of epinephrine spoils anti-pruritic effect of butorphanol against epidural morphine

Scientific Title:Acronym

Co-use of epinephrine and butorphanol

Region

Japan

Condition

gynecological open surgery; abdominal-hysterectomy, hysterosalpingo-oophorectomy, and salpingo-oophorectomy

Classification by specialty

Obstetrics and Gynecology

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study was aimed to elucidate the hypothesis that co-use of epinephrine with anti-pruritic drug should afford further reduction of pruritus associated with epidural morphine after gynecological open surgeries.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III

Primary outcomes

Primary endpoint was the incidence of pruritus during the postoperative 24 hours.

Key secondary outcomes

The following measures were selected at the secondary endpoint: incidences of dizziness, incidences of postoperative emesis (none, nausea, retching, and vomiting), intensities of postoperative wound pain: Visual analogue scales (VAS, mm: 0 = no pain, 100 = worst pain imaginable, at rest and at coughing), and incidences of side effects.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

control group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with no epinephrine.

Interventions/Control_2

E0.15 group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with 0.15 mg epinephrine.

Interventions/Control_3

E0.3 group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with 0.3 mg epinephrine.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

ASA physical status 1-2

Key exclusion criteria

Patients were excluded from the study if one or more of the following criteria were met: allergy to opioids, concurrent use of antidepressants or analgesics, smoking habit, medical histories of chronic inflammatory disease and motion sickness, severe obesity (BMI > 25), contraindications to epidural catheterization such as infection, anatomical abnormalities of the spine, or full anticoagulation.

Target sample size

95

Name of lead principal investigator

1st name
Middle name
Last name	Kohei Kawashima

Organization

Wakayama Medical University

Division name

Department of Anesthesiology

Zip code

Address

811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Wakayama Medical University

Division name

Department of Anesthesiology

Zip code

Address

811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan

TEL

073-447-2300

Homepage URL

Email

whisky_finger@yahoo.co.jp

Institute

Japanese Red Cross Society Wakayama Medical Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本赤十字社和歌山医療センター（和歌山県）

Date of disclosure of the study information

2012

Year

09

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

The incidence of pruritus in E0.3 (35.5 %) was significantly higher compared with E0.15 (9.7 %). The incidence of dizziness in control (16.1 %) was significantly lower compared with E0.15 (48.4 %, p=0.013) or E0.3 (45.2 %, p=0.026). Other data did not differ significantly among the groups. (2008 ASA Annual Meeting in Orlando)

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2007

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2007

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

28

Day

Last modified on

2012

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010557