UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052551 |
|---|---|
| Receipt number | R000059965 |
| Scientific Title | A Randomized Controlled trial to compare the efficacy of intraperitoneal instillation of Bupivacaine with Lidocaine for post-operative pain relief in patients undergoing Laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2023/10/20 03:17:11 |
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Basic information
Public title
A Randomized Controlled trial to compare the efficacy of intraperitoneal instillation of Bupivacaine with Lidocaine for post-operative pain relief in patients undergoing Laparoscopic cholecystectomy
Acronym
PReACh
Scientific Title
A Randomized Controlled trial to compare the efficacy of intraperitoneal instillation of Bupivacaine with Lidocaine for post-operative pain relief in patients undergoing Laparoscopic cholecystectomy
Scientific Title:Acronym
PReACh
Region
| Asia(except Japan) |
Condition
Condition
Gall stone disease
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of intra-peritoneal Lidocaine with intra-peritoneal L-bupivacaine irrigation of diaphragmatic surface and gallbladder fossa (prior to dissection and post-dissection of Gall Bladder) on post-operative morbidity in terms of:
1. Post-operative pain (To be assessed by VAS, HR, SBP, DBP and MAP)
2. Post-operative shoulder tip pain
3. Post-operative nausea and vomiting
4. Need for post-operative rescue analgesia
5. Duration of hospitalization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-operative pain as assessed by Visual analog score, heart rate, mean arterial pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A-Lidocaine instillation before gall bladder (GB) dissection
Interventions/Control_2
Group B-Lidocaine instillation after GB dissection
Interventions/Control_3
Group C-L-Bupivacaine instillation before GB dissection
Interventions/Control_4
Group D-L-Bupivacaine instillation after GB dissection
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with symptomatic Cholelithiasis/ GB sludge (dyspepsia, pain)
2. Patients with asymptomatic gall stones disease.
3. Solitary polyps of more than 6 mm or multiple gall bladder polyps or progressively enlarging gall bladder polyp
Key exclusion criteria
1. Conversion from Laparoscopic to open cholecystectomy
2. Patients with Jaundice
3. Intra-operative detection of concomitant pathology in other organs (Appendix, bowel, liver, stomach)
4. Duration of surgery more than 90 minutes
5. Any Patient in whom Drain was placed after Surgery
6. Allergies to L-Bupivacaine/Lidocaine
Target sample size
176
Research contact person
Name of lead principal investigator
| 1st name | Aishwainee |
| Middle name | |
| Last name | VG |
Organization
Sikkim Manipal Institute of Medical Sciences
Division name
Department of General Surgery, Central Referral Hospital
Zip code
737102
Address
Department of General Surgery, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok
TEL
8867710850
aishwainee@gmail.com
Public contact
Name of contact person
| 1st name | Aishwainee |
| Middle name | Viswabharathi |
| Last name | VG |
Organization
Sikkim Manipal Institute of Medical Sciences
Division name
Department of General Surgery, Central Referral Hospital
Zip code
737102
Address
Department of General Surgery, Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong
TEL
8867710850
Homepage URL
aishwainee@gmail.com
Sponsor or person
Institute
Sikkim Manipal Institute of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Research Protocol Evaluation Committee, SMIMS
Address
Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok
Tel
3592270535
smims@smu.edu.in
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
| 2023 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
295
Results
Better post-operative outcomes with IPLA instillation when done prior to GB dissection
No difference has been noted between the use of Lidocaine and L-Bupivacaine in the current study.
Results date posted
| 2023 | Year | 10 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Socio-demography
Intra-operative: duration of surgery, Intra-operative adhesions
Post-operative: Pain as per Visual analog score, Pulse rate, Mean arterial pressure, Shoulder tip pain
Participant flow
Total patients recruited in study: 295 (A:74; B: 73; C: 73; D: 75)
Patients excluded due to intraoperative findings: 120 (A:32: B:22; C:32; D:34)
Final number in each group: A/B/C/D- 42/51/41/41 (175 in total)
Adverse events
none
Outcome measures
Post operative pain relief as per visual analog score supplemented by the vital parameters including heart rate and mean arterial pressure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059965
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