| CTRI Number |
CTRI/2025/03/082551 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of stellate ganglion block on blood pressure and heart rate recorded inside operation room due to creation of pneumoperitoneum in adult patients under going laparoscopic gall bladder removal- A double blinded hospital based randomised controlled study |
|
Scientific Title of Study
|
Effects of stellate ganglion block on intraoperative hemodynamic responses to pneumoperitoneum in adult patients undergoing laparoscopic cholecystectomy- Hospital based randomised controlled trail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshitha R |
| Designation |
Post Graduate |
| Affiliation |
KLE university |
| Address |
Department of Anesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8884102991 |
| Fax |
|
| Email |
rakshpraj0809@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjunath C Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakshitha R |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
8884102991 |
| Fax |
|
| Email |
rakshpraj0809@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Charitable Hospital, Belagavi- 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Rakshitha R |
| Address |
Department of Anesthesiology
Jawaharlal Nehru Medical College
Nehru Nagar, Nelagavi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakshitha R |
KLEs Dr. Prabhakar Kore Charitable Hospital |
Department Of Anesthesiology KLEs Dr. Prabhakar Kore Charitable Hospital,
Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
8884102991
rakshpraj0809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (3) ICD-10 Condition: 4||Measurement and Monitoring, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administering Stellate Ganglion Block using 0.75% ropivacaine |
Administering 10ml of 0.75% ropivacaine into the right stellate ganglion under ultrasound guidance to participants of study group in the pre operative area before general anesthesia for laparoscopic cholecystectomy. |
| Comparator Agent |
Administering stellate ganglion block using normal saline. |
Administering 10ml of normal saline into right stellate ganglion under ultrasound guidance to participants of control group in the pre operative area before general anesthesia for patients undergoing laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2
Patients undergoing laparoscopic cholecystectomy
Patients belonging to age group of 18 to 60 years |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients allergic to ropivacaine
Patients with infection at the site of injection |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
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Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effects of the right stellate ganglion block on hemodynamic response to pneumoperitoneum in patients undergoing laparoscopic cholecystectomy |
To assess the heart rate, blood pressures at baseline, during laryngoscopy, during pneumoperitoneum, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the stress response to laryngoscopy & endotracheal intubation |
Baseline, Laryngoscopy, pneumoperitoneum, 5mins, 10 mins, 15 mins, 20 mins, 30 mins |
|
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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)
|
01/04/2025 |
| 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 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
|
This is double blinded randomized controlled trial recruiting 60 participants equally divided into two groups of study and control. Study group participants will receive ultrasound guided right sided stellate ganglion block using 10ml of 0.75% Ropivacaine in the preoperatively 15 mins before surgery. Whereas control group participants will receive ultrasound guided right sided stellate ganglion block using 10 ml of normal saline as a placebo. All the participants are induced in under general anesthesia according to standard institutional protocols. Patient baseline vitals will be monitored before the block, during laryngoscopy, intubation, pneumoperitonuem, 5 mins, 10 mins, 15 mins, 20 mins, 30 mins intraoperatively. Heart rate and mean arterial pressure values will be statistically analysed in both the groups to extrapolate the results of the study. |