| CTRI Number |
CTRI/2023/09/058005 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound-guided Erector Spinae plane block versus Subcostal transversus Abdominis block for post operative pain relief in laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of Ultrasound-guided Erector Spinae Plane block versus subcostal Transversus Abdominis block for post-operative analgesia in patients undergoing Laparoscopic Cholecystectomy |
| 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 Ankur Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 415, 3rd Floor , BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8360971576 |
| Fax |
|
| Email |
ankursharma99999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 415, 3rd Floor , BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No. 415, 3rd Floor , BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8360971576 |
| Fax |
|
| Email |
ankursharma99999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, JLN Marg New Delhi, 110002 |
| 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 Ankur Sharma |
Lok Nayak Hospital |
Department of Anesthesiology and Intensive care, BL Taneja block, Maulana Azad medical college,Lok Nayak Hospital,JLN Marg
New Delhi
Central
DELHI |
8360971576
ankursharma99999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
| Intervention |
Erector Spinae Plane Block |
The Erector Spinae Plane block will be performed after induction with the patient in the lateral
decubitus position by an experienced anesthesiologist. The lower end of the scapula and the spinous process of the T7 vertebra will be located while the patient lies in a lateral position. These areas will be then cleaned and sterilized with povidone iodine. A high-frequency linear ultrasound (US) probe shielded with a sterile sheath will be placed sagittal on the spinous process of the T7 vertebra, and then slid 3-em laterally in the parasagittal region. After the transverse process of the vertebra is visualized, a 100 mm, 22-gauge echogenic block needle will be advanced toward the interfascial plane between the erector spinae and the transverse process. Consequently, the separation caused by hydrodissection will be confirmed by administering 0.5-1 mL of normal saline. Then, a pre-prepared solution of 0.3 ml/kg of 0.25 % Bupivacaine (max. 20ml) will be injected into the space bilaterally. The craniocaudal spreading of the local anesthetic will be observed. The total duration of block intervention will be around 10-15 min. After completion of the ESP block, surgery will commence followed by block characteristics follow up till 24 hours including post operative analgesia and stress responses. |
| Comparator Agent |
Subcostal Transversus Abdominis Block |
Subcostal Transversus Abdominis block will be performed after induction with the patient in the supine position by an experienced anesthesiologist. The USG probe will be placed on the upper abdominal wall obliquely along the subcostal edge close to the midline. After identification of the Rectus Abdominis muscle (RAM), by shifting the probe obliquely along the subcostal line toward the lateral, the Transverses Abdominis muscle (TAM) will be located below the RAM. With the USG probe, a 100 mm, 22- gauge echogenic block needle will be placed between the RAM and TAM in the same plane (in-plane technique). A pre- prepared solution of 0.3ml/kg 0.25% bupivacaine (max. 20 ml) will be injected between these two muscles and observed to spread toward the lateral side of the RAM bilaterally. The total duration of block intervention will be around 10-15 min. After completion of the TAP block, surgery will commence followed by block characteristics follow up till 24 hours including post operative analgesia and stress responses. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.18 to 60 years of age
2.American Society of Anesthesiologists Grade I and
II.
|
|
| ExclusionCriteria |
| Details |
1.Bleeding or Coagulation
Abnormality
2.Local skin infection at the site of block
3.Pts on corticosteroids and immunosuppressive drugs
4.BMI >30 kg/m²
5.Allergy to study medications
6.Inability to understand Numerical Rating Scale (NRS |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to request for first supplemental analgesia in post-operative period . |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes (Heart rate & mean arterial pressure) before induction(baseline), after induction, post block, at skin incision and for every 15 minutes intraoperatively.
2.Post-operative NRS score till 24 hours.
3.Total amount of analgesic consumption in 24 hours postoperatively.
4.Blood levels of C-reactive proteins (CRP), Blood Glucose, Serum Cortisol and Total leucocyte count (TLC) before induction and 6 hours post-surgery.
5.Block related complications like Vascular injuries, block site pain, hematoma and local anesthetic systemic toxicity (LAST).
6.Patient satisfaction score by Likert Scale at 24 hours |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2023 |
| 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)
|
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
|
We are comparing Erector Spinae Plane Block with Subcostal Transversus Abdominis Block for post operative analgesia in patients posted for Laparoscopic Cholecystectomy in Lok Nayak Hospital Delhi. A total of 40 patients with 20 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. We will be using standard general anesthesia for induction of the patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain and time for first supplemental analgesia will determined. Overall patient satisfaction score will also be assesed . |