| CTRI Number |
CTRI/2021/04/033165 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
12/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Study to determine analgesic affect of erector spinae block when The patient receives an erector spinae block under ultrasound guidance before laparoscopic cholecystectomy so they dont experience pain after the surgery. |
|
Scientific Title of Study
|
Evaluation of efficacy of ultrasound guided erector spinae block for post-operative analgesia in patients undergoing laparoscopic cholecystectomies. |
| Trial Acronym |
EPSB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAMTA HARJAI |
| Designation |
Professor |
| Affiliation |
DR. RMLIMS |
| Address |
Dr Mamta Harjai, Department of Anaesthesiology, 2nd floor, Administration block, DR RMLIMS, Lucknow, Vibhuti Khand, Gomti Nagar, Lucknow(U.P)
Dr Mamta Harjai, Department of Anaesthesiology, 2nd floor, Administration block, DR RMLIMS, Lucknow, Vibhuti Khand, Gomti Nagar, Lucknow(U.P)
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007015 |
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMTA HARJAI |
| Designation |
Professor |
| Affiliation |
DR. RMLIMS |
| Address |
Dr Mamta Harjai, Department of Anaesthesiology, 2nd floor, Administration block, DR RMLIMS, Lucknow, Vibhuti Khand, Gomti Nagar, Lucknow(U.P)
Dr Mamta Harjai, Department of Anaesthesiology, 2nd floor, Administration block, DR RMLIMS, Lucknow, Vibhuti Khand, Gomti Nagar, Lucknow(U.P)
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007015 |
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini Gupta |
| Designation |
Junior Resident |
| Affiliation |
DR. RMLIMS |
| Address |
6th floor, Dr SC Rai Hostel, Dr. Ram Manohar Lohia Institute,Vibhuti khand, Gomti nagar, Lucknow.
6th floor, Dr Sc Rai hostel, Dr. Ram Manohar Lohia Institute,Vibhuti khand, Gomti nagar, Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7694908250 |
| Fax |
|
| Email |
ashwinigupta76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded Dr. mamta harjai,Dr. RML Institute of medical sciences,vibhuti khand,gomti nagar,Lucknow,226010 |
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute Of Medical Sciences |
| Address |
Dr. Ram Manohar Lohia Institute,Vibhuti khand, Gomti nagar, Lucknow |
| 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 |
| Dr Mamta Harjai |
Dr .Ram Manohar Lohia Institute of medical sciences |
Department of Gastrosurgery, 1st floor, DR. Ram Manohar Lohia Institute, Vibhuti khand, Gomti nagar, Lucknow
Lucknow
UTTAR PRADESH |
8176007015
mamtaharjaidoctor@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr RMLIMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Ultrasound guided erector spinae block |
USG guided erector spinae block will be given at T8 level with patient in sitting/supine position, 15ml of 0.375% ropivacaine on each side. Esp block will be given 30 minutes prior to shifting the patient to OT. Under ultrasound guidance the needle will be introduced between erector spinae muscle and transverse process and a small bolus of local anaesthetic will be administered, separating the erector spinae muscle from transverse process. This separation confirms the correct placement of the needle. The local anaesthetic will then be injected in 5 cc increments, with aspiration after each 5 cc to prevent intravascular injection. The patient will be monitored for 30 minutes and the effect will be checked by pin prick. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I and GRADE II patients.
BMI 20-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients who do not give consent for the procedure.
BMI>30 kg/m2.
ASA GRADE>II.
Patients on anticoagulants.
Contraindication to regional anaesthesia, eg local sepsis, coagulopathy, preexisting peripheral neuropathies.
Severe respiratory or cardiac disorders, pregnancy.
Patients with chronic pain conditions.
Patients with failure of ESP block.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to rescue analgesia. |
Time to rescue analgesia post operatively within first 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total intraoperative fentanyl consumption
|
Intraoperatively |
Total tramadol or other analgesic modality consumption in first 24 hours post operatively
|
in first 24 hours of surgery |
| VAS score at 2 hourly intervals post operatively at rest and upon coughing or mobility |
at 2 hourly intervals for first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/05/2021 |
| 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="1"
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)?
Response - NO
|
|
Brief Summary
|
- To determine the efficacy of erector spinae block for post operative analgesia in patients undergoing laparoscopic cholecystectomies as compared to control group.
- To observe for the detrimental effects of ESP BLOCK(if any)
|