UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the postoperative analgesic efficacy of periodic intravenous administration of acetaminophen after gynecologic laparoscopic surgery
Acronym	Periodic intravenous acetaminophen administration versus intravenous patient-controlled analgesia of fentanyl (gynecologic laparoscopic surgery)
Scientific Title	Assessment of the postoperative analgesic efficacy of periodic intravenous administration of acetaminophen after gynecologic laparoscopic surgery
Scientific Title:Acronym	Periodic intravenous acetaminophen administration versus intravenous patient-controlled analgesia of fentanyl (gynecologic laparoscopic surgery)
Region	Japan

Condition
Condition	uterine disease
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the postoperative analgesic efficacy of periodic intravenous acetaminophen with that of intravenous patient-controlled analgesia of fentanyl after total laparoscopic hysterectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of supplemental or rescue analgesic administration for 24 hours postoperatively
Key secondary outcomes	1)the pain score (numerical rating scale: NRS) at rest at 6, 12 and 24 hours postoperatively 2)satisfaction of the patient at 24 hours postoperatively 3)frequency of nausea and vomiting for 24 hours postoperatively 4)frequency of antiemetic administration for 24 hours postoperatively

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Periodic administration of acetaminophen dose:1000 mg (body weight over 50kg) or 15 mg/kg (body weight less than 50kg) timing:Primary dosage is administrated 30 minutes before the end of surgery and administrated total 4 times every 6 hours.
Interventions/Control_2	Intravenous patient-controlled analgesia with fentanyl continuous intravenous administration of fentanyl 0.4 mg in saline 50 ml is started after surgery with 2 ml/h. An additional 1 ml injection is allowed in painful case(max two times/h).
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1)Patients who weigh over 40 kg and less than 100 kg 2)Patients who undergo laparoscopic hysterectomy 3)Patients without liver dysfunction(AST>100IU/l,ALT>100IU/l.T-bil>1.8mg/dl) 4)Patients without renal dysfunction(CCr or eGFR<60ml/min) 5)Patients without allergy to acetaminophen, opioid and local anesthetics
Key exclusion criteria	1)Patients who weigh less than 40 kg and over 100 kg 2)Pregnant patients 3)Patients with nervous, heart, respiratory complications 4)Patients with allergy to acetaminophen, opioid and local anesthetics 5)Patients taking antipsychotics 6)Patients with liver and renal dysfunction 7)Patients who cannot understand pain scale 8)Patients who cannot obtain agreements 9)Patients who need additional open incision
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Namiko Middle name Last name Hashimoto
Organization	Nippon Life Hospital
Division name	Obstetrics and Gynecology
Zip code	5500006
Address	2-1-54 Enokojima, Nishi-ku, Osaka
TEL	06-6443-3446
Email	namikosaka@aol.com

Public contact
Name of contact person	1st name Namiko Middle name Last name Hashimoto
Organization	Nippon Life Hospital
Division name	Obstetrics and Gynecology
Zip code	5500006
Address	2-1-54 Enokojima, Nishi-ku, Osaka
TEL	06-6443-3446
Homepage URL
Email	namikosaka@aol.com

Sponsor
Institute	Nippon Life 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	Nippom Life Hospital
Address	2-1-54 Enokojima, Nishi-ku, Osaka
Tel	06-6443-3446
Email	namikosaka@aol.com

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	2019 Year 10 Month 01 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	129
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	2019 Year 09 Month 11 Day
Date of IRB	2019 Year 09 Month 11 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 01 Day
Last modified on	2021 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043495