| CTRI Number |
CTRI/2021/09/036754 [Registered on: 22/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Novel use of Erector spinae block during laparoscopic surgeries |
|
Scientific Title of Study
|
Efficacy of erector spinal block during laparoscopic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandip baheti |
| Designation |
Professor |
| Affiliation |
Dr.D.Y. Patil medical college,hospital and research centre |
| Address |
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumedha Biswas |
| Designation |
Resident |
| Affiliation |
Dr.D.Y. Patil medical college,hospital and research centre |
| Address |
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9094042623 |
| Fax |
|
| Email |
biswasumedha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumedha Biswas |
| Designation |
Resident |
| Affiliation |
Dr.D.Y. Patil medical college,hospital and research centre |
| Address |
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9094042623 |
| Fax |
|
| Email |
biswasumedha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia department Hitech building 5th floor
Dr D Y Patil Medical College, hospital and Research centre
Sant tukaram nagar pimpri 411018 maharashtra |
|
|
Primary Sponsor
|
| Name |
DrDYpatil medical collegehospital and research centre |
| Address |
Dr.D.Y.patil medical college,hospital and research centre,Pimpri,pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sandip baheti |
Dr D Y Patil Medical College Hospital and Research Centre |
Anaesthesia department Hitech building 5th floor
Sant tukaram nagar pimpri 411018
Pune
MAHARASHTRA |
9822014401
sandipbaheti1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub-committee,DPU,pune |
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 |
| Intervention |
Efficacy of erector spinal block during laparoscopic surgeries |
25 patients will be given ultrasound guided erector spinae block using 0.25% bupivacaine 20ml bilaterally at T5 Spinous process prior to the inducton of general anaesthesia and effects will be observed for he duration of surgery |
| Comparator Agent |
General Anaesthesia during laparoscopic surgeries |
25 patients will be given general anaesthesia. After preoxygenation with 100% oxygen for three minutes, patients will be premedicated with injection glycopyrrolate 0.004mg/kg, injection midazolam 0.2mg/kg and fentanyl 2mcg/kg intravenously. Anesthesia will be induced with injection propofol 2mg/kg intravenously and neuromuscular blockade will be given using 0.5mg/kg Atracurium intravenously, patient will be intubated using appropriate sized cuffed endotracheal tube and maintained on sevoflurane with oxygen and nitrous oxide at 50% concentration for the duration of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa grade 1 and 2
Patients undergoing laparoscopic surgeries under general anaesthesia
Haemodynamically stable patients with all routine investigations within normal limits without comorbidities
Patients not on any cardiac related drugs
|
|
| ExclusionCriteria |
| Details |
Asa 3 or more
Patients posted for emergency procedure
Major neurological,cardiac,respiratory,metabolic,renal,hepatic diseases with coagulation abnormalities
Cardiac comorbidities
Patients refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of erector spinae block for haemodynamic stability during laparoscopic surgeries |
Heart rate, systolic and diastolic blood pressure will be monitored at baseline, at induction of pneumoperitoneum, and every 10 mins thereafter untill the completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The amount of Fentanyl required intraoperatively and the amount of inhalational agent required intraoperatively will be measured. |
The amount of fentanyl required intraoperatively, given in aliquots whenever heart rate or blood pressure increases 20% above the baseline values will be recorded for the duration of surgery. The amount of inhalational agent (Isoflurane) used intraoperatively during the period of surgery will be measured. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/09/2021 |
| 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 Applicable |
| 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)?
|
|
Brief Summary
|
To determine the effectiveness of erector spinae block for haemodynamic stability during laparoscopic surgeries Performed under general anaesthesia using 20 cc of 0.25 bupivacaine |