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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043712
Receipt No. R000049908
Scientific Title A comparison of two injection approaches for rectus sheath block in laparoscopic inguinal hernia repair
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/23

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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 Preinitiation
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
2022 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
2021 Year 03 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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