UMIN-CTR Clinical Trial

Public title

Investigation of the influence of analgesic medication during surgery on postoperative pain

Acronym

Analgesic medication and postoperative pain

Scientific Title

Investigation of the influence of analgesic medication during surgery on postoperative pain

Scientific Title:Acronym

Analgesic medication and postoperative pain

Region

Japan

Condition

General anesthetic patient

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate whether opioid administered during surgery causes postoperative hyperalgesia.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Postoperative hyperalgesia, pressure pain threshold

Key secondary outcomes

Postoperative Pain, Numeric rating scale

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

moderate dose of opioid administration during operation

Interventions/Control_2

low dose of opioid administration during operation

Interventions/Control_3

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

60

years-old

>

Gender

Female

Key inclusion criteria

Benign Gynecological Disease

Key exclusion criteria

Severe systemic disease
Chronic opioid use

Target sample size

30

Name of lead principal investigator

1st name	Tomohiko
Middle name
Last name	Aoe

Organization

Teikyo University

Division name

Chiba Medical Center, Pain Center

Zip code

299-0111

Address

3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan

TEL

0436-62-1211

Email

tomohikoA@med.teikyo-u.ac.jp

Name of contact person

1st name	Tomohiko
Middle name
Last name	Aoe

Organization

Teikyo University

Division name

Chiba Medical Center, Pain Center

Zip code

299-0111

Address

3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan

TEL

0436-62-1211

Homepage URL

Email

tomohikoA@med.teikyo-u.ac.jp

Institute

Teikyo University

Institute

Department

Personal name

Organization

Teikyo University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects

Address

2-11-1 Kaga, Itabashi-Ku, Tokyo 173-8605, Japan

Tel

+81-3-3964-7256

Email

turb-office@teikyo-u.ac.jp

Secondary IDs

YES

Study ID_1

18-074

Org. issuing International ID_1

Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京大学ちば総合医療センター (Teikyo University Chiba Medical Center)

Date of disclosure of the study information

2018

Year

11

Month

26

Day

URL releasing protocol

https://researchmap.jp/multidatabases/multidatabase_contents/detail/289920/67aa3093ab73eefe0e26c01bb

Publication of results

Published

URL related to results and publications

https://www.mdpi.com/2077-0383/11/19/5587

Number of participants that the trial has enrolled

30

Results

The pressure pain threshold at 3 h postoperatively was 51.1% (95% CI: [44.4-57.8]) in group A and 56.6% [49.5-63.6] in group B, assuming a preoperative value of 100% (P = 0.298). There were no significant differences in pressure pain threshold and numeric rating scale scores between the groups after surgery. The pain threshold decreased significantly in both groups at 3 h postoperatively compared to preoperative values, and recovered at 24 h.

Results date posted

2023

Year

12

Month

02

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Female patients in their 20s to 50s with benign ovarian or uterine disease, who were scheduled for laparoscopic surgery under general anesthesia were eligible for participation in the study if they had American Society of Anesthesiologists (ASA) physical status classification scores of I (normal healthy patient) or II (with mild systemic disease). Patients were not eligible if they were pregnant or breastfeeding, had cognitive impairment with difficulties in pain evaluation, had any contraindications to use of the drugs included in the protocol, or had a history of chronic opioid use before surgery. There was no particular weight limit for the patient, but the smaller value between the actual body weight and the ideal body weight, 22 x (height in m)2 kg, was used in this study to avoid drug overdose.

Participant flow

Patients were recruited until the planned number was achieved. During preoperative anesthesia consultation, an independent anesthesiologist evaluated the eligibility of applicants, obtained informed consent, and registered participants. Patients were randomly assigned in a 1:1 ratio into either of the 2 groups by the permuted block method using the RAND function in Microsoft Excel (Microsoft Corporation, Redmond, USA); this was performed by the secretary under the supervision of an independent researcher. Sealed envelopes containing the group allocation and study number details were opened on the day of the operation. The patient and investigators who evaluated the pain intensity and threshold were blinded to group allocation. An independent anesthesiologist opened the sequentially numbered envelope containing details regarding randomization assignment, and administered general anesthesia according to the protocol.

Adverse events

No anesthesia-related adverse events were observed during and after surgery.

Outcome measures

Primary outcome
Difference between the two groups in terms of the pressure pain threshold value at 3h
after the end of surgery, assuming that the value on the day before surgery was 100%.

Secondary outcomes
1. Difference between the two groups in terms of pressure pain threshold value at 24 h
after the end of operation.
2. Difference between the two groups in terms of numeric rating scale scores at 0-3 h, 3 h,
and 24 h after the end of operation.

Explorative outcomes
1. Difference between the two groups in terms of the frequency of analgesic (including
flurbiprofen, acetaminophen and pentazocine) use in the hospital room during 24 hours
after surgery.
2. Changes in postoperative pressure pain threshold and numeric rating scale score values
in each group compared to those before surgery.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2018

Year

10

Month

05

Day

Date of IRB

2018

Year

10

Month

05

Day

Anticipated trial start date

2018

Year

11

Month

26

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

21

Day

Last modified on

2023

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039864