UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038175 |
|---|---|
| Receipt number | R000043495 |
| Scientific Title | Assessment of the postoperative analgesic efficacy of periodic intravenous administration of acetaminophen after gynecologic laparoscopic surgery |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/04/03 14:28:42 |
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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
| Obstetrics 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
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
namikosaka@aol.com
Sponsor or person
Institute
Nippon Life Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043495
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