UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043712 |
|---|---|
| Receipt number | 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 | 2022/11/25 12:38:37 |
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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
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
hiroshia@terra.dti.ne.jp
Sponsor or person
Institute
Nagasaki Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049908
