UMIN-CTR 臨床試験登録情報の閲覧

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
Email	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
Email	dr_mhegazy7000@mans.edu.eg

Sponsor
Institute	Mansoura university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043985