| CTRI Number |
CTRI/2025/09/094559 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Recovery in Mothers After Planned Cesarean Comparing Lower Back Injection and Ultrasound-Guided Abdominal injection |
|
Scientific Title of Study
|
Comparison of Impact of Intrathecal Morphine With Ultrasound-guided Transversus Abdominis Plane Block on Patient Reported Quality Of Recovery following elective Caesarean delivery : A Non-Inferiority Randomized Trial
|
| 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 Abhishek Jadhav |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of anesthesiology, pain medicine and critical care, Room no 5011 teaching Block AIIMS New Delhi
South Delhi
New Delhi
DELHI
110029
India |
| Phone |
8888196274 |
| Fax |
|
| Email |
abhishekajpatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshul Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of anesthesiology, pain medicine and critical care, Room no 5011 teaching Block AIIMS New Delhi
South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9999056767 |
| Fax |
|
| Email |
ansh.dadoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of anesthesiology, pain medicine and critical care, Room no 5011 teaching Block AIIMS New Delhi
South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9999056767 |
| Fax |
|
| Email |
ansh.dadoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, Ansari Nagar East, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New 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 |
| Dr Abhishek Jadhav |
Aiims New Delhi |
Department of Anaesthesiology,Pain Medicine and Critical Care, Aiims New Delhi- 110029
South Delhi
New Delhi
DELHI |
8888196274
abhishekajpatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics Committee for post graduate research AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Morphine |
This group receives subarachnoid injection of Bupivacaine heavy (10-11mg, discretion of anaesthesiologist) with 20µg fentanyl, with 100 µg preservative-free intrathecal morphine. Sensory block level of spinal anesthesia will be confirmed to reach T6 using the pinprick test before initiating Cesarean delivery |
| Intervention |
Transversus abdominis plane block |
This intervention group receives subarachnoid injection of Bupivacaine heavy (10-11mg, discretion of anaesthesiologist)) with 20µg fentanyl. Sensory block level of spinal anesthesia will be confirmed to reach T6 using the pinprick test before initiating CD. Ultrasound-guided bilateral TAP block (0.375% Ropivacaine 1.5 mg/kg at each side to a maximum of 20ml ) will be performed after surgical closure
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Parturients more than 18 years undergoing elective caesarean delivery under spinal anesthesia.
ASA physical status II-III.
Able to provide informed consent & complete questionnaire in Hindi
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindication to spinal anesthesia, ITM or TAP block
General anesthesia planned/required
Chronic opioid use
Significant hepatic/renal impairment
Coagulopathy
BMI more than 40 kg/m²
Patient at extremes of height.
Active infection at injection sites
Medical illness which requires admission high dependency unit
Medical barrier which would prevent patient from completing the ObsQoR form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the quality of recovery at 24 hours post cesarean delivery, measured by the total ObsQoR-11Hindi score, between patients randomized to receive ITM versus those randomized to receive TAP block, within a non-inferiority framework.
|
To compare the quality of recovery at 24 hours post cesarean delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain intensity with movement (NRS 0-10) (e.g., during transfer/coughing) at 3, 6, 12 and 24 hours post-delivery.
Time to first request for rescue opioid analgesia (in minutes).
Total cumulative iv tramadol consumption during first 24 hours post delivery.
Incidence and severity of PONV (e.g., using PONV Impact Scale) after delivery, followed by 3, 6, 12, 24 hours post delivery.
Incidence and severity of Pruritus (using 4 point scale) recorded prospectively over 24 hours.
Incidence of respiratory depression.
Time (hours) from end of surgery to first independent ambulation (e.g., walking to bathroom)
Time (hours) from end of surgery to first passage of flatus.
|
3,6,12 and 24hrs |
|
|
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)
|
21/09/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Low dose ITM (50-100 mcg) has been recommended by various guidelines as postoperative analgesic technique after CS, as part of multimodal analgesia regimen. But its use is still not prevalent worldwide, due to its bothersome side effects, pruritus and nausea and vomiting. When compared to ITM, TAP has been found to have comparable or slightly less effective analgesia(on the basis of time to fist rescue analgesia), but is associated with a better side-effect profile. Therefore, within the multimodal analgesia framework, we aim to compare the two to explore whether TAP leads to a non inferior overall quality of recovery (QoR). If TAP block demonstrates non-inferior QoR, it provides a valuable alternative to the standard treatment of ITM, as a part of post-cesarean multimodal analgesia regimen, especially for patients at high risk for opioid side effects (e.g., OSA, severe PONV/pruritus history) and in settings where long-acting opioids cannot be used due to paucity of resources. |