UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of two injection approaches for rectus sheath block in laparoscopic inguinal hernia repair
Acronym	A comparison of two injection approaches for rectus sheath block in laparoscopic inguinal hernia repair
Scientific Title	A comparison of two injection approaches for rectus sheath block in laparoscopic inguinal hernia repair
Scientific Title:Acronym	A comparison of two injection approaches for rectus sheath block in laparoscopic inguinal hernia repair
Region	Japan

Condition
Condition	inguinal hernia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pain at the laparoscopic port insertion site is a postoperative complaint in patients undergoing laparoscopic inguinal hernia repair. Although opioid-based analgesia is extremely effective, it is associated with postoperative side effects such as nausea and vomiting. Multimodal analgesia has recently become well-established because it reduces opioid use by combining non-opioid analgesics with a peripheral nerve block. Rectus sheath block (RSB) and transverse abdominis plane block are effective peripheral nerve blocks for laparoscopic surgery. RSB is simple to perform when surgical incisions are localized to the abdominal midline. Local anesthetic is injected into the space between the rectus abdominis muscle and the posterior layer of the rectus sheath, and spread lenticularly within this space. However, a potential complication of RSB is an internal injury due to peritoneal puncture. Injecting the local anesthetic into the rectus abdominis muscle produces an analgesic effect, reduces the likelihood of peritoneal puncture, and improves the safety of the procedure. We present a comparison of the analgesic effect achieved using the conventional RSB method with injection into the rectus sheath (hereinafter, original method), and the intramuscular RSB method involving injection into the rectus abdominis muscle (intramuscular method).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain level (numerical rating scale), and nausea at 1, 4, 6, and 12 hours after completion of surgery
Key secondary outcomes	the time from the nerve block to the first additional analgesic dose number of additional analgesic doses

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	0.25% levobupivacaine 48mL administration into the rectus abdominis muscle under ultrasound guidance, before skin incision.
Interventions/Control_2	Ultrasound-guided rectus abdominis sheath block, with 0.25% levobupivacaine 48mL, before skin incision.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients weighing 50-80kg, with American Society of Anesthesiologists physical status 1-2, who underwent laparoscopic inguinal hernia repair.
Key exclusion criteria	Patients with coagulation disorder, impaired hepatic or renal function, and abnormal platelet counts were excluded from the study.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Aoki
Organization	Nagasaki Rosai Hospital
Division name	Department of anesthesia
Zip code	857-0134
Address	2-12-5, Setogoe, Sasebo City, Nagasaki, Japan
TEL	0956-49-2191
Email	hiroshia@terra.dti.ne.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Aoki
Organization	Nagasaki Rosai Hospital
Division name	Department of anesthesia
Zip code	857-0134
Address	2-12-5, Setogoe, Sasebo City, Nagasaki, Japan
TEL	0956-49-2191
Homepage URL
Email	hiroshia@terra.dti.ne.jp

Sponsor
Institute	Nagasaki Rosai Hospital
Institute
Department

Funding Source
Organization	Japan Organization of Occupational Health and Safety
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	Nagasaki Rosai Hospital
Address	2-12-5, Setogoe, Sasebo City, Nagasaki, Japan
Tel	0956-49-2191
Email	shomu@nagasakih.johas.go.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	長崎労災病院(長崎県)

Other administrative information
Date of disclosure of the study information	2021 Year 04 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
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	2020 Year 10 Month 09 Day
Date of IRB	2020 Year 10 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2024 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	2021 Year 03 Month 23 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049908