| CTRI Number |
CTRI/2019/02/017802 [Registered on: 25/02/2019] Trial Registered Prospectively |
| Last Modified On: |
24/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of bupivacaine for post operative pain in patients undergoing surgery for gall stone disease laparoscopically |
|
Scientific Title of Study
|
Efficacy of high-volume low- concentration intraperitoneal bupivacaine irrigation for post operative analgesia in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SWATI PANWAR |
| Designation |
POST GRADUATE STUDENT IN MD ANAESTHESIOLOGY |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
3rd FLOOR, BL TANEJA BLOCK,
MAULANA AZAD MEDICAL COLLEGE,
BAHADUR SHAH ZAFAR MARG
Central
DELHI
110002
India |
| Phone |
9873774094 |
| Fax |
|
| Email |
panwarswati182@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR J S DALI |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
3rd FLOOR, BL TANEJA BLOCK,
MAULANA AZAD MEDICAL COLLEGE,
BAHADUR SHAH ZAFAR MARG
Central
DELHI
110002
India |
| Phone |
9968604212 |
| Fax |
|
| Email |
dr_dali@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SWATI PANWAR |
| Designation |
POST GRADUATE STUDENT IN MD ANAESTHESIOLOGY |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
3rd FLOOR, BL TANEJA BLOCK,
MAULANA AZAD MEDICAL COLLEGE,
BAHADUR SHAH ZAFAR MARG
Central
DELHI
110002
India |
| Phone |
9873774094 |
| Fax |
|
| Email |
panwarswati182@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS |
|
|
Primary Sponsor
|
| Name |
SWATI PANWAR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
3rd FLOOR, B L TANEJA BLOCK
MAULANA AZAD MEDICAL COLLEGE,
BAHADUR SHAH ZAFAR MARG,
NEW DELHI-110002 |
| 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 SWATI PANWAR |
MAULANA AZAD MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY,
3RD FLOOR,B L TANEJA BLOCK,
MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS, BAHADUR SHAH ZAFAR MARG
New Delhi
DELHI |
9873774094
panwarswati182@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ADULT PATIENTS OF EITHER SEX, SCHEDULED FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bupivacaine(study) group |
20 ml of 0.5% bupivacaine(100mg) added to 480 ml of normal saline which will then be used for intraperitoneal irrigation |
| Comparator Agent |
normal saline group |
500 ml of normal saline will be used for intraperitoneal irrigation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PHYSICAL STATUS I/II
2. SCHEDULED FOR ELECTIVE LAPAROSCOPIC
CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
1. ALLERGY TO LOCAL ANAESTHETICS
2. ACUTE PANCREATITIS
3. CHOLEDOCHOLITHIASIS
4. CURRENT ANALGESIC USE
5. INABILITY TO COMPREHEND NRS( NUMERIC PAIN
RATING SCALE)
6. PREGNANCY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA |
time interval between removal of airway device and first requirement of rescue analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-NUMERIC PAIN RATING SCALE
-TOTAL DOSE OF RESCUE
ANALGESIC IN 24 HRS
-INCIDENCE OF SHOULDER PAIN
-INCIDENCE OF NAUSEA AND
VOMITING |
IMMEDIATELY AFTER EXTUBATION
15 MIN.
30 MIN.
1,2,4,6,8,12,24 HRS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/02/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Effective post operative analgesia after laparoscopic cholecystectomy remains a clinical challenge. Recently, instillation of different local anaesthetics (LAs) intraperitoneally has gained popularity for post-operative analgesia in laparoscopic cholecystectomy. Most of the studies have used bupivacaine irrigation of peritoneal cavity in low volume(20ml to 100ml) and high concentration(0.125%-0.5%). However, their analgesic action is effective for only a few hours in the post-operative period. Recently low concentration(0.02%) but high volume (500 ml) of bupivacaine has been used for intraperitoneal irrigation in order to cover large sub hepatic area and surrounding peritoneum thereby producing more effective analgesia. It significantly increased duration of analgesia and reduced opioid requirement after laparoscopic cholecystectomy. |