| CTRI Number |
CTRI/2026/01/102261 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Newer Method Of Pain Relief For Laparascopic Cholecystectomy |
|
Scientific Title of Study
|
" To Study the efficacy and safety of 0.5% Levobupivacaine application at calots triangle for cases of mini laparotomy cholecystectomy " |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College, Swaroop Nagar, Kanpur
UP
Department Of Anaesthesia
GSVM Medical College, Swaroop Nagar, Kanpur
UP
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Mishra |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP
Department Of Anaesthesia
GSVM Medical College
Swaroop Nagar
Kanpur
UP
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Department Of Anaesthesia
GSVM Medical College,
Swaroop Nagar
Kanpur
UP
Department Of Anaesthesia
GSVM Medical College,
Swaroop Nagar
Kanpur
UP
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neha Mishra |
| Address |
Department Of Anaesthesia
GSVM Medical College,
Swaroop Nagar
Kanpur
UP- 208002 |
| 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 Neha Mishra |
GSVM MEDICAL COLLEGE, KANPUR |
Department Of Anaesthesia
GSVM Medical College,
Swaroop Nagar
Kanpur
Kanpur Nagar
UTTAR PRADESH |
08874311115
dr.nehamishra86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM MEDICAL COLLEGE, KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine Heavy 5% |
Soaked Gauge Put On Calots Triangle
5 ml
placed only once
patient will be followed for 24 hours postoperative |
| Comparator Agent |
Normal Saline |
Soaked Gauze In Calots Triangle
5 ml
placed only once
patient will be followed for 24 hours postoperative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II |
|
| ExclusionCriteria |
| Details |
Acute cholecystitis
converted to open surgery
contraindication to local anaesthetic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Score In Post Operative Period
Rescue Analgesia
Duration Of Hospital Stay |
2,4,6,8,12,24,36 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Stability |
2,4,6,8,12,24,36 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
by supplementing analgesia in the form of soaked lignocaine heavy 5 % and comparing it with normal saline in mini lap cholecystectomy, we can see the duration of post operative analgesia, need for rescue analgesia, duration of hospital stay in both the groups.
|