UMIN-CTR Clinical Trial

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
Email	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
Email	kei-y7of@fmu.ac.jp

Sponsor
Institute	Aidu 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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042030