| CTRI Number |
CTRI/2022/03/041499 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of An Ultrasound guided Nerve Block given in the Upper Back On Heart Rate And Blood Pressure In Patients With High Blood Pressure Undergoing Laparoscopic Gall Bladder Surgery Under Anaesthesia |
|
Scientific Title of Study
|
A Randomized Control Trial To Study The Effect Of Erector Spinae Plane Block On Hemodynamic Changes In Response To Pneumoperitoneum In Hypertensive Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology,
Lady Hardinge Medical College
New Delhi - 110001
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
anug71@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology,
Lady Hardinge Medical College
New Delhi - 110001
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
anug71@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Megha Mansukhani |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology,
Lady Hardinge Medical College
New Delhi - 110001
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
mansukhanimegha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College,
Shaheed Bhagat Singh Marg,
Connaught Place,
New Delhi - 110001 |
| 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 Megha Mansukhani |
Lady Hardinge Medical College |
Surgery OT, Main OT complex, Department of Anaesthesiology
Central
DELHI |
8860750751
mansukhanimegha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block given with general anaesthesia |
Erector spinae plane block with 20ml of 0.25% bupivacaine plain given on both sides at t7 transverse process along with general anaesthesia |
| Comparator Agent |
General anaesthesia |
Only general anaesthesia given, and no nerve block given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients with age more than/equal to 18 years with controlled hypertension (systolic blood pressure less than/equal to 140mm Hg and diastolic blood pressure less than/equal to 90mm Hg) |
|
| ExclusionCriteria |
| Details |
a) Known allergy to any of the drugs used.
(b) Impaired coagulation or on anticoagulant drugs. (c) Surgery converted to open cholecystectomy. (d) Surgery taking >3hrs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean of hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) in both groups. |
a) Baseline
(b) Before induction
(c) After intubation
(d) Before insufflation of carbon dioxide
(e) 10 minutes after creating pneumoperitoneum, and every 10 minutes thereafter.
(f) 10 minutes after exsufflation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical rating scale for pain |
0,6,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
04/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Although the effect of erector spinae plane block on attenuation of hemodynamic parameters has been studied in non-laparoscopic surgeries such as lumbar spine surgery, but it has not been studied in laparoscopic surgeries to the best of our knowledge. Attenuating hemodynamic response to pneumoperitoneum is important for better patient outcome, especially in hypertensive population. Therefore, we have planned this study to study the effect of erector spinae plane block on the hemodynamic response to pneumoperitoneum in hypertensive patients undergoing laparoscopic cholecystectomy under general anaesthesia. |