| CTRI Number |
CTRI/2025/10/096656 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| 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 the effect of general anaesthesia and the regional anaesthesia through a needle in the back on the functions of lung for gall bladder removal surgery |
|
Scientific Title of Study
|
Comparative analysis of incidence of atelectasis during
elective laparoscopic cholecystectomy: Thoracic segmental spinal anaesthesia with
isobaric levo bupivacaine versus general anaesthesia in adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravneet Kaur Gill |
| Designation |
Assistant professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravneet Kaur Gill |
| Designation |
Assistant professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravneet Kaur Gill |
| Designation |
Assistant professor |
| Affiliation |
Dr B R Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Dept of Anaesthesia, OT complex, first floor, Block 1, Dr B R Ambedkar State Institute of Medical Sciences, Mohali
PUNJAB
160055
India |
| Phone |
9501988361 |
| Fax |
|
| Email |
drravneetkgill@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar State Institute of Medical Sciences, Mohali, Punjab. India 160055 |
|
|
Primary Sponsor
|
| Name |
Dr Ravneet Kaur Gill |
| Address |
Dept of Anaesthesia, Dr B R Ambedkar State Institute of Medical Sciences, Mohali. Punjab. India 160055 |
| 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 Ravneet Kaur Gill |
Dr B R Ambedkar State Institute of Medical Sciences |
Dr B R Ambedkar State Institute of Medical Sciences,Sector 56, Mohali. Punjab. 160055
Rupnagar
PUNJAB |
9501988361
drravneetkgill@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - HUMAN RESEARCH (IEC-HR) |
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 |
| Comparator Agent |
General anaesthesia |
Group II (n=50): will receive general anaesthesia as per the institutional protocol at the start of surgery (as mentioned in methodology) |
| Intervention |
Thoracic segmental spinal anaesthesia |
Group I (n=50): will receive TSSA with isobaric levobupivacaine 7.5 mg (1.5 ml, 0.5%) with fentanyl (25
micrograms) at the start of the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Males or females aged 18-65 years undergoing laparoscopic cholecystectomy surgeries.
ASA PS- I-II patients |
|
| ExclusionCriteria |
| Details |
Patients with a history of allergy to local anesthetics
Hemodynamically unstable patients, with sepsis
Coagulopathy
Significant liver or renal disease
Patients with local site infection
Patients with any spinal deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the post operative atelectasis based on ultrasonography
(Modified lung ultrasound score) among the two groups |
Before surgery, 20 minutes in post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intra-operative hemodynamic parameters among the two groups |
0,1,2,3,4,5,10,15,20,25,30,40,5,60.75,90 minutes intraoperative |
To compare the VAS scores and time for first rescue analgesia in the postoperative period among the
two groups |
0,1,2,3,6,12,24 hours post operative |
| To compare the cost effectiveness among the two groups. |
post operative |
To compare the readiness of discharge from PACU to ward using Modified Aldrete score among the
two groups |
post operative |
| To compare the post operative recovery based on QoR 15 score among the two groups |
24 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/11/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drravneetkgill@gmail.com].
- For how long will this data be available start date provided 09-10-2025 and end date provided 09-10-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Laparoscopic cholecystectomy is one of the most common surgical procedures performed worldwide. It has revolutionized surgical practice by reducing morbidity and hospital stays. However, anaesthetic techniques play a crucial role in ensuring optimal peri-operative outcomes. General anaesthesia (GA) is traditionally used for laparoscopic procedures, but thoracic segmental spinal anaesthesia (TSSA) has emerged as a promising alternative. GA remains the gold standard for laparoscopic procedures, providing adequate anaesthetic depth, muscle relaxation, and airway protection. However, GA is associated with certain drawbacks such as postoperative nausea and vomiting (PONV), respiratory complications, hemodynamic fluctuations, and prolonged recovery times. Thoracic segmental spinal anaesthesia may be used as an alternative for such surgeries. It is gaining popularity due to its better safety profile and reduction in post-operative pain. Various local anaesthetics have been used in TSSA which include hyperbaric or isobaric bupivacaine, ropivacaine, or lately levo- bupivacaine. Along with these, various adjuvants have also found their place in the literature namely fentanyl, dexmedetomidine, sufentanil, etc. Most of the literature has compared TSSA with general anaesthesia establishing its significance in various thoraco-abdominal surgeries, but on searching the literature, we did not find many studies that compared the TSSA with local anaesthetics isobaric levobupivacaine- fentanyl for assessment of post operative atelectasis. Hence we propose this study to compare the incidence of post operative atelectasis of isobaric levobupivacaine-fentanyl in thoracic segmental spinal anaesthesia and general anesthesia in patients undergoing laparoscopic cholecystectomy surgeries. |