| CTRI Number |
CTRI/2025/07/091511 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing two nerve block techniques to control pain after caesarean delivery. |
|
Scientific Title of Study
|
Comparison of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post operative analgesia after caesarean section under spinal anaesthesia. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahla Parveen |
| Designation |
Postgraduate Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care,
VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
Thekkepurath house, Palachuvadu, Kakkanad P.O, Kochi ,682030,Kerala
South
DELHI
110029
India |
| Phone |
9847174452 |
| Fax |
|
| Email |
parveensahla26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRanju Gandhi |
| Designation |
Director Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care,
VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrRanju Gandhi |
| Designation |
Director Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care,
VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi 110029, India |
| 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 |
| DrSahla Parveen |
Vardhman Mahavir medical college and Safdarjung hospital, New Delhi |
Department of anaesthesia and intensive care, main OT complex , ground floor.
South
DELHI |
9847174452
parveensahla26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College Institutional Ethics Committee |
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 |
Erector spinae plane block |
The ESP blocks will be performed with patients in the right lateral decubitus position. Using USG correct space will be identified and confirmed.Bupivacaine 0.25% 20 mL with dexmedetomidine (0.25 micrograms/cc) will be injected under vision. This procedure will be then repeated on the other side of the spine. |
| Intervention |
Transversus abdominis plane block |
The TAP blocks will be performed in the supine position, using a linear (6-13 MHz) ultrasound transducer. After sterilization of the skin, a 21 gauge 100 mm echogenic needle will be introduced from anterior to posterior, and confirmation of correct needle placement will be made by separation of the muscle layers with sterile saline hydro dissection. After aspiration to exclude intravascular injection, bupivacaine 0.25% 20 mL with 0.25 mcg dexmedetomidine will be injected under vision. This procedure will be then repeated on the other side of the abdomen. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists physical status II, or III normal singleton pregnancy (with a gestational age of at minimum 37 weeks) undergoing caesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Any contraindication to spinal anaesthesia (systemic coagulopathy, anatomic abnormalities, localized infection), known allergy to study medication, inability to comprehend or participate in pain scoring system. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post op analgesia after caesarean section under spinal anaesthesia by assessing the time for first rescue analgesia. |
Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, and 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual analogue scale (resting & dynamic) will be assessed at rest & on movement at
intervals of 6 hourly till 24 hours & the 12 hourly till 48 hours. (0,6,12,24,36,48 hours).
|
Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, & 48 hours. |
| 2.Total tramadol consumption for 48 hours |
Calculated at the end of 48 hours. |
| 3.Adverse effects if any like hypotension, bradycardia, sedation. |
Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, & 48 hours. |
| 4.Severity of pain interference with performance of activities of daily living (ADL) breastfeeding, & general care (cleaning, changing, comforting) of the infant. ADLs assessed will include include changing position in bed, standing & walking, & eating |
Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, & 48 hours. |
| 5.Patient’s overall satisfaction score at discharge using 0-5 score (0 = worst ,1= very bad, 2 = bad, 3 = good, 4 = very good, 5 = best). |
Assessed at time of discharge. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a prospective interventional randomised comparative study to compare erector spinae plane block with transversus abdominis plane block with dexmedetomidine as an adjuvant for post operative analgesia after caesarean section under spinal anaesthesia with the hypothesis that the use of erector spinae plane block is comparable to transversus abdominis plane block with dexmedetomidine as adjuvant for post operative analgesia for caesarean section under spinal anaesthesia.Primary objective is to compare the analgesic efficacy of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post op analgesia after caesarean section under spinal anaesthesia by assessing the time for first rescue analgesia.Secondary objectives are visual analogue scale (resting and dynamic) will be assessed at rest and on movement at intervals of 6 hourly till 24 hours and the 12 hourly till 48 hours. (0,6,12,24,36,48 hours),total tramadol consumption for 48 hours ,adverse effects if any like hypotension, bradycardia, sedation,severity of pain interference with performance of activities of daily living (ADL) breastfeeding, and general care (cleaning, changing, comforting) of the infant. ADLs assessed will include include changing position in bed, standing and walking, and eatingpatient’s overall satisfaction score at discharge using 0-5 score (0 = worst ,1= very bad, 2 = bad, 3 = good, 4 = very good, 5 = best).The sample size studied would be 80, ie, 40 per group.
|