| CTRI Number |
CTRI/2022/07/044059 [Registered on: 15/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare post operative pain relief of combination of two drugs (intraperitoneal irrigation of bupivacaine plus hydrocortisone) vs one drug (bupivacaine alone) in patients undergoing laparoscopic surgery for removal of gall bladder. |
|
Scientific Title of Study
|
A comparative study of impact on Post-operative analgesia with intraperitoneal irrigation of high volume low concentration bupivacaine plus hydrocortisone vs bupivacaine alone in patients undergoing elective cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA SHUKLA |
| Designation |
ASSISTANT PROFESOR |
| Affiliation |
BMCRI |
| Address |
Department of anestheia,
3rd floor, centennary building
victoria hospital,fort road,
bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9945659167 |
| Fax |
|
| Email |
divyashukla17sep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DIVYA SHUKLA |
| Designation |
ASSISTANT PROFESOR |
| Affiliation |
BMCRI |
| Address |
Department of anestheia,
3rd floor, centennary building
victoria hospital,fort road,
bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9945659167 |
| Fax |
|
| Email |
divyashukla17sep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aji Khan |
| Designation |
P.G. Student |
| Affiliation |
BMCRI |
| Address |
Department of Anesthesia,
3rd floor, Centennary building
Victoria hospital, Fort road,
Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
8310387855 |
| Fax |
|
| Email |
ajikhan5255@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bengaluru Medical College And Research Institute, Fort Road, Bengaluru- 560002 |
|
|
Primary Sponsor
|
| Name |
Bengaluru Medical College And Research Institute |
| Address |
Bengaluru Medical College And Research Institute, Fort Road, Bengaluru- 560002 |
| Type of Sponsor |
Government medical college |
|
|
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 Divya Shukla |
Bangalore Medical College And Research Institute |
Victoria Hospital, Dept of Anesthesiology, Bangalore Medical College And Research Institute
KR Road, Near KR Market, Bangalore.
Bangalore
KARNATAKA |
9945659167
divyashukla17sep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College And Reseach Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Volume low concentration Bupivacaine |
Intraperitoneal irrigation of High Volume low concentration Bupivacaine as a form of post op analgesia |
| Intervention |
High Volume low concentration Bupivacaine with Hydrocortisone |
Intraperitoneal irrigation of High Volume low concentration Bupivacaine with Hydrocortisone as a form of post op analgesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give written informed consent.
Patients with ASA Grade 1 and 2.
Patients scheduled for elective laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
1. PATIENT REFUSAL
2. ALLERGY TO LOCAL ANESTHETIC DRUGS
3. PATIENTS WITH ACUTE PANCREATITIS,CHRONIC PAIN,
CHOLEDOCHOLITHIASIS
4. PATIENTS WITH CHRONIC OPIOID USE, CHRONIC NSAID
USE
5. INABILITY TO COMPREHEND VAS
6. PATIENTS WITH CONVERSION OF LAPAROSCOPIC
CHOLECYSTECTOMY TO OPEN CHOLECYSTECTOMY. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesic |
Time to first rescue analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesic requirement |
first 24 hours |
| Time to Ambulation |
First 24 hours |
| Total episodes of vomiting |
first 24 hours |
| incidence of shoulder pain |
first 48 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy has become a preferred modality of treatment in gall bladder surgeries. It is the gold standard for the treatment of symptomatic cholelithiasis and chronic cholecystitis. Pain is a frequent complaint following laparoscopic cholecystectomy(LC). Pain in LC can be divided into components such as parietal ,viscera and shoulder pain.Visceral pain accounts for most of the discomfort experienced in the early post operative period.Intensity quickly decreases after the first 24hrs post operatively.Shoulder tip pain dominates as visceral pain decreases. The surgical stress and insufflation of abdomen with CO2 causing rapid distention of the peritoneum may result in tearing of blood vessels ,traumatic traction of the nerves and release of inflammator meiators causing pain.Pneumoperitoneum with CO2 is thought to cause phrenic nerve irritation secondarily causing referred shoulder tip pain. Various drugs and methods have been studied to effectively counter these undesirable effect . Local anaesthetics have been observed to be effective in providing post operative analgesia in patients undergoing laparoscopic cholecystectomy .Some studies have observed that intraperitoneal Bupivacaine does not reduce pain after laparoscopic cholecystectomy , but these studies used high concentration low volume bupivacaine intraperitoneally. It has been demonstrated that use of bupivacaine as low concentration high volume intraperitoneal irrigation,intraoperatively is effective in prolonging the duration of analgesia reduces post operative rescue analgesic requirement in the initial 24 hr without significant postoperative adverse effects. |