UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036883 |
|---|---|
| Receipt number | R000042030 |
| Scientific Title | The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after a cesarean section |
| Date of disclosure of the study information | 2019/05/29 |
| Last modified on | 2020/07/21 13:47:59 |
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Basic information
Public title
The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after a cesarean section
Acronym
The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after a cesarean section
Scientific Title
The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after a cesarean section
Scientific Title:Acronym
The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after a cesarean section
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effectiveness of intramuscular quadratus lumborum block for postoperative analgesia after cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to first analgesic use after cesarean section
Key secondary outcomes
number of analgesic use within 24 hours after surgery, postoperative numerical rating scale (NRS) (0, 2, 4, 6, 8, 10, 12, 24, 48 hours after surgery), presence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1) Before surgery, spinal anesthesia is performed from the L3/4 (or L2/3) with 2.0-2.2 mL of 0.5% hyperbaric bupivacaine and 15 mcg (0.3 mL) of fentanyl
2) Depending on cases, droperidol about 1 mg administered soon after delivery
3) Acetaminophen 1000 mg is administrationed in 15 min at the end of surgery in all cases
After the surgery, in the control group, 0.4 ml/kg of normal saline is injected into bilateral quadratus lumborum muscle under ultrasound-guided (total volume is 0.8 ml/kg).
Interventions/Control_2
In the intramuscular QLB group, spinal anesthesia and intraoperative management as same as control group are performed. However, after surgery, 0.25% ropivacaine 0.4 mL/kg is administered bilaterally as intramuscular QLB (total volume is 0.8 mL/kg). The total amount of ropivacaine used is 2 mg/kg.
Because this study is a double-blind study, patient, anesthesiologist performed block techniques and ward staff are not imformed which drug (normal saline/ropivacaine) is used. All cases are managed as administered ropivacaine. Patients can use some analgesics whenever they need after surgery.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who scheduled for elective cesarean section under spinal anesthesia at our hospital after May 2019, and fulfill all the following 3 items
1)20 years old or older
2)American Society of Anesthesiologists Physical Status (ASA-PS) 2
3)Written informed consent is obtained
Key exclusion criteria
Any of the following items
1) multiple pregnancy
2) obesity: Body Mass Index 30 kg/m2 or more (at the time of surgery)
3) Less than 37 weeks of pregnancy
4) allergy to any drug used in this study;
5) History of neuropsychiatric disorders
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Aidu Chuo Hospital
Division name
Department of Anesthsiology
Zip code
965-8611
Address
1-1, Tsurugamatchi, Aizuwakamatsu, Fukushima, Japan
TEL
0242-25-1515
kei-y7of@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Aidu Chuo Hospital
Division name
Department of Anesthsiology
Zip code
965-8611
Address
1-1, Tsurugamatchi, Aizuwakamatsu, Fukushima, Japan
TEL
0242-25-1515
Homepage URL
kei-y7of@fmu.ac.jp
Sponsor or person
Institute
Aidu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Ethics Committee of Aidu Chuo Hospital
Address
1-1, Tsurugamatchi, Aizuwakamatsu, Fukushima, Japan
Tel
0242-25-1515
kanoh@onchikai.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
会津中央病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00540-020-02829-0
Number of participants that the trial has enrolled
36
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 | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042030
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