UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036390 |
|---|---|
| Receipt number | R000041462 |
| Scientific Title | Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2019/04/04 |
| Last modified on | 2024/04/05 17:04:26 |
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Basic information
Public title
Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Acronym
Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Scientific Title
Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Scientific Title:Acronym
Analgesic effects of transversus abdminis plane block with additional of magnesium sulfate to local anesthetic: a prospective randomized controlled study in patients after laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
Acute cholecystitis
Cholelithiasis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the analgesic effects of additional of a magnesium sulfate to local anesthetic for transversus abdminis plane block in patients after laparoscopic cholecystectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric rating scale at 24h after operation
Key secondary outcomes
Numeric rating scale at time of exit operating room
Numeric rating scale at 3, 6,12h after operation
Time when the patient first used analgesic
postoperative nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Additional of magnesium sulfate 300 mg to local anesthetics used for transversus abdminis plane block
Interventions/Control_2
Only local anesthetics are used for sciatic nerve block
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 who schedulled for a laparoscopic cholecystectomy with renging from 20 to 80 years.
American Society of Anesthesiologists physical status 1-2
Key exclusion criteria
Body mass index >=35
American Society of Anesthesiologists physical status >=3
dementia
renal disorder
history of a local anesthesia allergy
Neuromuscular or neurological disorder
Psychiatric problem
Coagulation disorder
history of a Hypermagnesemia
pregnant or at lactation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Iwata |
Organization
Nayoro City General Hospital
Division name
Department of Anesthesiology
Zip code
096-0042
Address
8-1 Minami, Nishi7, Nayoro-city, Hokkaido, Japan
TEL
01654-3-3101
kyokui100006@gmail.com
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Iwata |
Organization
Nayoro City General Hospital
Division name
Department of Anesthesiology
Zip code
096-0042
Address
8-1 Minami, Nishi7, Nayoro-city, Hokkaido, Japan
TEL
01654-3-3101
Homepage URL
kyokui100006@gmail.com
Sponsor or person
Institute
Nayoro City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nayoro City General Hospital
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
none
Address
none
Tel
none
none
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041462
Publication of results
Unpublished
Result
URL related to results and publications
https://search.jamas.or.jp/search/do/detail/sidx/3/sid/2
Number of participants that the trial has enrolled
28
Results
The primary endpoint, the numerical rating scale (NRS) at 24 hours after surgery, did not differ significantly.
There was a significant difference in postoperative NRS only in the immediate postoperative period. The median (interquartile range) NRS immediately after surgery was 4.5 (1.0-5.0) in the R group and 0.0 (0.0-2.3) in the M group, P value 0.007. There were no significant differences in other parameters.
Results date posted
| 2024 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with American Society of Anesthesiologists physical status classification (ASA) I or II, aged 20 to 80 years, who underwent a laparoscopic cholecystectomy performed at our institution from April 2019 to December 2019 on a standby basis were included.
Patients who did not give consent, BMI of 35 or higher, ASA III or higher, dementia, renal dysfunction, muscular, neurological, or psychiatric disease, coagulation abnormalities, hypermagnesemia or local anesthesia toxicity, pregnant or lactating women were excluded.
Participant flow
Twenty-eight patients who underwent standby laparoscopic cholecystectomy at our hospital from April 2019 to December 2019 were included. Of these, 3 patients were excluded preoperatively due to non-consent or history of chronic renal failure. One patient who underwent endoscopic retrograde cholangiopancreatography (ERCP) the day after surgery for a stone in the bile duct was also excluded. The final number of patients in the R and M groups was 12 each.
Adverse events
none
Outcome measures
The primary endpoint was the Numeric rating scale (NRS) at 24 hours after the end of surgery.
Secondary endpoints were pain at the end of surgery and pain at 3, 6, and 12 hours after surgery, respectively, as assessed by the NRS. The time of initial analgesic use and the presence of postoperative nausea and vomiting (PONV) were also evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 04 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041462
