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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000023021 |
Receipt No. | R000025005 |
Scientific Title | Efficacy of ultrasound-guided quadrutum lumbar block for postoperative analgesia of gynecological laparoscopic surgery |
Date of disclosure of the study information | 2016/07/05 |
Last modified on | 2016/10/04 |
Basic information | ||
Public title | Efficacy of ultrasound-guided quadrutum lumbar block for postoperative analgesia of gynecological laparoscopic surgery | |
Acronym | ultrasound-guided quadrutum lumbar block for postoperative analgesia of gynecological laparoscopic surgery | |
Scientific Title | Efficacy of ultrasound-guided quadrutum lumbar block for postoperative analgesia of gynecological laparoscopic surgery | |
Scientific Title:Acronym | ultrasound-guided quadrutum lumbar block for postoperative analgesia of gynecological laparoscopic surgery | |
Region |
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Condition | ||
Condition | Patients who undergo gynecologic laparoscopic surgery. | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the postoperative analgesia efficacy by quadrutum lumborum block. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Postoperative pain |
Key secondary outcomes | Number of analgesics administration
Postoperative nausea |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Perform quaduratus lumborum block | |
Interventions/Control_2 | Do not perform quadrutus lumborum block | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Gynecologic patients who undergo laparoscopic surgery | |||
Key exclusion criteria | Patients with open surgery | |||
Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Medical College | ||||||
Division name | Anesthesiology | ||||||
Zip code | |||||||
Address | 2-7 Daigaku-machi, Takatsuk city | ||||||
TEL | 072-696-2121 | ||||||
ane022@poh.osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Medical College | ||||||
Division name | Anesthesiology | ||||||
Zip code | |||||||
Address | 2-7Daigaku-machi, Takatsuki city | ||||||
TEL | 0726-84-6361 | ||||||
Homepage URL | |||||||
ane078@poh.osaka-med.ac.jp |
Sponsor | |
Institute | Osaka Medical College |
Institute | |
Department |
Funding Source | |
Organization | Osaka Medical College |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Pain in movement and in rest was significantly smaller in QLB group than in Control group. |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Nausea was significantly higher in QLB group than in Control group immediately and 24 hours after general anesthesia. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025005 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |