UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036883
Receipt No. 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 2019/06/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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) (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

Not applicable
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) 1 or 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 30

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Yoshida
Organization Aizu Chuo Hospital
Division name Department of Anesthsiology
Zip code 965-8611
Address 1-1, Tsurugamatchi, Aizuwakamatsu, Fukushima, Japan
TEL 0242-25-1515
Email kei-y7of@fmu.ac.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Yoshida
Organization Aizu Chuo Hospital
Division name Department of Anesthsiology
Zip code 965-8611
Address 1-1, Tsurugamatchi, Aizuwakamatsu, Fukushima, Japan
TEL 0242-25-1515
Homepage URL
Email kei-y7of@fmu.ac.jp

Sponsor
Institute Aizu Chuo Hospital
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
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 03 Month 31 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
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042030

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.