| CTRI Number |
CTRI/2023/01/048937 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate post operative analgesic effects of intraperitoneal instillation of bupivacaine with morphine and bupivacaine with buprenorphine for laproscopic cholecystectomy |
|
Scientific Title of Study
|
Evaluation of post operative analgesic effects of intraperitoneal instillation of bupivacaine with morphine and bupivacaine buprenorphine for laparoscopic cholecystectomy : A double blind comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kumar PB |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9448279414 |
| Fax |
|
| Email |
drrameshkumarpb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geethanjali P |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9739945846 |
| Fax |
|
| Email |
geetp11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niveditha B |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medial Sciences |
| Address |
Department of Anesthesiology, BGS Global Institute of Medial
Sciences No.67, BGS Health and Education City, Uttarahalli
Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9590377700 |
| Fax |
|
| Email |
nivibasuraj94@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institute of
Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Kumar PB |
| Address |
Department of Anesthesiology, BGS Global Institute of Medical
Sciences, No.67, BGS Health and Education City, Uttarahalli Road,
Kengeri, Bangalore 560060 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Kumar PB |
BGS Global Institute of Medical Sciences |
Major OT Complex, 3rd
Floor, Department of
Anesthesiology BGS
Global Institute of
Medial Sciences No.67,
BGS Health and
Education City,
Uttarahalli Road,
Kengeri
Bangalore
KARNATAKA |
9448279414
drrameshkumarpb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine and Buprenorphine |
Single Injection of 0.25% Bupivacaine and 0.3 mg Buprenorphine |
| Comparator Agent |
Bupivacaine and Morphine |
Single Injection of 0.25% Bupivacaine and 2mg Morphine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent.
2. ASA physical status I and II patients.
3. Patients undergoing elective laparoscopic surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patients having a known allergy to the study drug.
2. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess analgesic effects |
Pain Assessment will be done at 0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Safety of drugs |
0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"Nil" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized, Double-Blinded study to asess, compare and evaluate post operative analgesic effects of intraperitoneal instillation of 25ml 0.25% bupivacaine and 2mg morphine versus 25ml 0.25% bupivacaine and 0.3mg buprenorphine to provide effective post operative pain relief in patients undergoing laparoscopic cholecystectomy under general anesthesia. Pre anaesthetic examination will be done and standard NPO guidelines will be followed. Premedication inj.pantoprazole 40mg intravenous, inj.ondansteron 4mg intravenous will be given Patients aged between 18year and 60year belonging to American Society of Anaesthesiology (ASA) I and II were randomized into two groups i.e BM and BB group BM group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 2mg morphine and BB group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 0.3mg buprenorphine and these medications will be given after peritoneal wash and suctioning through intraperitoneal instillation .The drug solution will be prepared by doctor who does not participate in the study. All patients will receive same anaesthesia method in each group. Patients in each group will be monitored for electrocardiogram(ECG),heart rate ,oxygen saturation (SpO2 saturation) and non invasive blood pressure(NIBP), end tidal carbon dioxide(EtCO2) Post operative pain will be evaluated using Visual Analog scale (pain score 0 -10) and verbal rating scale(VRS) for 24hrs after surgery .The post operative pain outcome will be reported at 0 and 30min 1,4,8,12,16,24hr. The cut off value for VAS is 4 for indication of rescue analgesic . At VAS>= 4 ,rescue analgesics will be administered on request, inj. diclofenac sodium75mg intravenously post operatively. |