UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038595 |
|---|---|
| Receipt number | R000043985 |
| Scientific Title | Effect of different concentrations of intraperitoneal bupivacaine on postoperative outcome in morbidly obese patients undergoing laparoscopic bariatric surgery |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2019/11/15 16:02:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of different concentrations of intraperitoneal bupivacaine on postoperative outcome in morbidly obese patients undergoing laparoscopic bariatric surgery
Acronym
effect of different concentrations of intraperitoneal bupivacaine on pain and respiratory functions post bariatric surgery
Scientific Title
Effect of different concentrations of intraperitoneal bupivacaine on postoperative outcome in morbidly obese patients undergoing laparoscopic bariatric surgery
Scientific Title:Acronym
effect of different concentrations of intraperitoneal bupivacaine on pain and respiratory functions post bariatric surgery
Region
| Africa |
Condition
Condition
recruiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare effect of different concentrations of intraperitoneal bupivacaine as a method for pain relief after laparoscopic bariatric surgery. The outcomes are visual analogue score, the time to first analgesic request, total analgesic requirement and changes of pulmonary functions. The other outcomes are incidence of difficulty of breathing, incidence rate of nausea and vomiting and return of bowel function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total analgesic requirements within 24 hours post operative
Key secondary outcomes
1-changes in respiratory functions measurements within 24 hours postoperative
2-time to first analgesic request
3-visual analogue scale measurement of pain within 24 hours postoperative
4-any reported side effects as difficulty of breathing, nusea or vomiting
5-return of bowel function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
group 1 placebo group (n=40): patients receive 40 ml of normal saline 0.9% will be streamed at the surgical site and the other half will be streamed into the coelomic cavity prior to deflation
Interventions/Control_2
group 2 intraperitoneal bupivacaine 25% group (n=40): patients receive 40 ml bupivacaine 25% half of the total volume will be streamed at the surgical site and the other half will be streamed into the coelomic cavity prior to deflation
Interventions/Control_3
group 3 Intraperitoneal bupivacaine125% group (B) (n=40) patients receive 40 ml of bupivacaine 125% will be delivered and streamed by the same manner
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
morbidly obese patients undergoing laparascoic bariatric surgery whose body mass index >35 . ASA I and II.
Key exclusion criteria
patient refusal,neuromuscular diseases (as myopathies, myasthenia gravie),psychiatric, hepatic, renal and cardiac diseases,known intolerance to the study drugs or patients converted to open surgery.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | mohammed |
| Middle name | adel |
| Last name | hegazy |
Organization
Mansoura university
Division name
anesthesia ans surgical intensive care department
Zip code
35511
Address
algomhoreya street, mansoura, egypt
TEL
00201002025982
dr_mhegazy7000@mans.edu.eg
Public contact
Name of contact person
| 1st name | mohammed |
| Middle name | adel |
| Last name | hegazy |
Organization
Mansoura university
Division name
anesthesia ans surgical intensive care department
Zip code
35511
Address
algomhoreya street, mansoura, egypt
TEL
00201002025982
Homepage URL
dr_mhegazy7000@mans.edu.eg
Sponsor or person
Institute
Mansoura university
Institute
Department
Personal name
Funding Source
Organization
Mansoura university
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
egyptian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mansoura faculty of medicine Institutional Research Board
Address
Mansoura faculty of medicine, algomhoreya street, mansoura, egypt
Tel
00201121102929
irb.mfm@hotmail.com
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 | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | 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 | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043985
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
