UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between shoulder pain after gynecologic laparoscopic surgery and choice of gas evacuation method and neuromuscular blockade: a retrospective study
Acronym	Relationship between shoulder pain after gynecologic laparoscopic surgery and choice of gas evacuation method and neuromuscular blockade: a retrospective study
Scientific Title	Relationship between shoulder pain after gynecologic laparoscopic surgery and choice of gas evacuation method and neuromuscular blockade: a retrospective study
Scientific Title:Acronym	Relationship between shoulder pain after gynecologic laparoscopic surgery and choice of gas evacuation method and neuromuscular blockade: a retrospective study
Region	Japan

Condition
Condition	Shoulder pain after laparoscopic surgery
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The COVID epidemic led to changes in laparoscopic gas evacuation and anesthesia methods for laparoscopic surgery at our hospital. By examining the impact of these changes on postoperative shoulder pain, we will consider preventive measures to reduce the incidence of shoulder pain in the future.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between the incidence of shoulder pain up to the third postoperative day and the choice of gas evacuation method and neuromuscular blockade.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who underwent gynecological laparoscopic surgery under general anesthesia at Ohama Dai-ichi Hospital from May 1, 2020 to October 30, 2020 (before the introduction of active degassing) and from December 1, 2020 to May 31, 2021 (after the introduction of active degassing)
Key exclusion criteria	Emergency surgery cases Re-surgery cases
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Misuzu Middle name Last name Hayashi
Organization	Omotokai Ohama Dai-ichi Hospital
Division name	Department of Anesthegiology
Zip code	9000005
Address	1000, Ameku, Naha-City, Okinawa-prefecture
TEL	098-866-5171
Email	koba_shu1982@yahoo.co.jp

Public contact
Name of contact person	1st name Misuzu Middle name Last name Hayashi
Organization	Omotokai Ohama Dai-ichi Hospital
Division name	Department of Anesthesiology
Zip code	9000005
Address	1000, Ameku, Naha-City, Okinawa-prefecture
TEL	098-866-5171
Homepage URL
Email	koba_shu1982@yahoo.co.jp

Sponsor
Institute	Omotokai Ohama Dai-ichi Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Omotokai Ohama Dai-ichi Hospital Ethics Committee
Address	1000, Ameku, Naha-City, Okinawa-prefecture
Tel	098-866-5171
Email	koba_shu1982@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	251
Results
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

Progress
Recruitment status	Completed
Date of protocol fixation	2022 Year 06 Month 01 Day
Date of IRB	2022 Year 06 Month 07 Day
Anticipated trial start date	2022 Year 06 Month 07 Day
Last follow-up date	2022 Year 09 Month 01 Day
Date of closure to data entry	2022 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 06 Month 01 Day
Last modified on	2022 Year 12 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054607