| CTRI Number |
CTRI/2025/09/094864 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE STUDY OF TRANSVERSUS ABDOMINIS PLANE BLOCK VERSUS QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING CESAREAN SECTION |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF TRANSVERSUS ABDOMINIS PLANE BLOCK VERSUS QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER SEGMENT CAESAREAN SECTION |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHASHANK KUMAR SRIVASTAV |
| Designation |
RESIDENT, DEPT. ANAESTHESIOLOGY AND CRITICAL CARE |
| Affiliation |
Command Hospital Air Force, Bangalore |
| Address |
2nd FLOOR, MAIN BUILDING, DEPARTMENT OF ANAESTHESIA & CRITICAL CARE, COMMAND HOSPITAL AIRFORCE BANGALORE, CAMBRIDGE ROAD, JOGUPALAYA, BENGALURU, KARNATAKA - 560007
Bangalore
KARNATAKA
560007
India |
| Phone |
09948715654 |
| Fax |
|
| Email |
dr.shashankksrivastava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wg Cdr Dr. Gaurav Pandey |
| Designation |
ASSOCIATE PROFESSOR,, DEPT. ANAESTHESIOLOGY AND CRITICAL CARE |
| Affiliation |
Command Hospital Air Force, Bangalore |
| Address |
COMMAND HOSPITAL AIRFORCE BANGALORE, CAMBRIDGE ROAD, JOGUPALAYA, BENGALURU, KARNATAKA - 560007
Bangalore
KARNATAKA
560007
India |
| Phone |
7607770085 |
| Fax |
|
| Email |
gpafg5196@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHASHANK KUMAR SRIVASTAV |
| Designation |
RESIDENT, DEPT. ANAESTHESIOLOGY AND CRITICAL CARE |
| Affiliation |
Command Hospital Air Force, Bangalore |
| Address |
2nd floor, DEPT OF ANAESTHESIA & CRITICAL CARE, COMMAND HOSPITAL AIRFORCE BANGALORE, CAMBRIDGE ROAD, JOGUPALAYA, BENGALURU, KARNATAKA - 560007
Bangalore
KARNATAKA
560007
India |
| Phone |
09948715654 |
| Fax |
|
| Email |
dr.shashankksrivastava@gmail.com |
|
|
Source of Monetary or Material Support
|
| COMMAND HOSPITAL, AIRFORCE BANGALORE |
|
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Primary Sponsor
|
| Name |
COMMAND HOSPITAL AIRFORCE BANGALORE |
| Address |
COMMAND HOSPITAL AIR FORCE, BANGALORE |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHASHANK KUMAR SRIVASTAV |
Command Hospital Air Force, Bangalore |
COMMAND HOSPITAL AIRFORCE BANGALORE, CAMBRIDGE ROAD, JOGUPALAYA, BENGALURU, KARNATAKA - 560007
Bangalore
KARNATAKA |
09948715654
dr.shashankksrivastava@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GP CAPT JITESH GOEL, MEMBER SECRETARY, IEC |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Ropivacaine injection only |
Using Inj Ropivacaine which is cardiac safe.
Dose:25 ml of 0.375% ropivacaine injected for transverus abdominis plane and quadratus lumborum plane block.
Freq: Once post operatively.
Checked effect of drug: at 2, 4, 6, 12 and 24 hours using Post operative pain assessment.
|
| Comparator Agent |
ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK VERSUS QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER SEGMENT CAESAREAN SECTION |
This study involves a clinical intervention on patients undergoing Lower Segment Caesarian Section surgery. The subjects will receive an ultrasound-guided Transversus Abdominis or Quadratus Lumborum block with 0.75% Ropivacaine for post operative analgesia. No animal subjects are involved. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
The inclusion criteria for this study are carefully defined to ensure a homogeneous study population, minimize confounding variables, and enhance the validity of the comparison between TAP and QL blocks for postoperative analgesia in LSCS. The criteria are designed to select patients who are likely to benefit from regional anaesthesia and whose clinical characteristics align with the study’s objectives. The following inclusion criteria are applied:
1. Age Range: Participants must be adult women aged 18 to 40 years. This age range encompasses the typical reproductive age group for cesarean deliveries, ensuring that the study population is representative of the target demographic. It also minimizes age related physiological variations that could affect pain perception or anaesthetic response.
2. ASA Physical Status I or II: Patients are included if they are classified as ASA I (healthy individuals with no systemic disease) or ASA II (individuals with mild systemic disease that does not limit activity, controlled hypertension or mild asthma). This criterion ensures that participants are generally healthy or have well managed conditions, reducing the risk of anaesthesia related complications and ensuring that pain outcomes are not confounded by severe comorbidities.
3. No History of Chronic Pain or Opioid Use: Patients with no history of chronic pain conditions (fibromyalgia, chronic pelvic pain) or long-term opioid use are included. This criterion minimizes baseline differences in pain perception and opioid tolerance, which could skew the study’s pain and analgesic consumption outcomes.
4. Ability to Provide Informed Consent: Participants must be capable of understanding the study’s purpose, procedures, and risks and provide written informed consent. This ensures ethical compliance and confirms that patients are willing to adhere to the study protocol, including postoperative assessments.
5. No Allergies to Local Anaesthetics: Patients with no known allergies to local anaesthetics (
0.75 of Ropivacaine). This criterion is critical to ensure the safety of the block administration and avoid adverse reactions that could confound the study results.
These inclusion criteria are applied during the preoperative screening process, typically conducted by the research team in collaboration with obstetricians and anaesthesiologists. Patients are assessed through medical history reviews, physical examinations, and laboratory tests (if needed) to confirm eligibility. The criteria are designed to create a study population that is clinically stable, representative of the typical LSCS patient, and suitable for evaluating the analgesic efficacy of TAP versus QL blocks. By adhering to these inclusion criteria, the study ensures that the results are generalizable to a broad population of parturient undergoing LSCS while minimizing variables that could affect the reliability of the comparison between the two regional anaesthesia techniques.
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| ExclusionCriteria |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the duration of postoperative analgesia provided by TAP and QL blocks. Duration of analgesia will be defined as the time from completion of the block to the first request for rescue analgesia. This objective helps in determining which block provides longer-lasting pain relief postoperatively.
2. To evaluate postoperative pain scores at specified intervals using the Visual Analogue Scale (VAS) Pain will be assessed using the VAS at rest and on movement at predetermined time intervals post-surgery—such as at 2, 4, 6, 12, and 24 hours. This will help establish the trajectory of pain control offered by each block.
3. To quantify and compare the total amount of rescue analgesic consumption in the first 24 hours postoperatively. The need for additional analgesics, including non-opioid and opioid medications, will be recorded. A lower requirement would reflect a more effective block.
|
1. To assess and compare the duration of postoperative analgesia provided by TAP and QL blocks. Duration of analgesia will be defined as the time from completion of the block to the first request for rescue analgesia. This objective helps in determining which block provides longer-lasting pain relief postoperatively.
2. To evaluate postoperative pain scores at specified intervals using the Visual Analogue Scale (VAS) Pain will be assessed using the VAS at rest and on movement at predetermined time intervals post-surgery—such as at 2, 4, 6, 12, and 24 hours. This will help establish the trajectory of pain control offered by each block.
3. To quantify and compare the total amount of rescue analgesic consumption in the first 24 hours postoperatively. The need for additional analgesics, including non-opioid and opioid medications, will be recorded. A lower requirement would reflect a more effective block.
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To study the influence of each block on early ambulation andreturn to normal activities postsurgery. Parameters such as time to mobilization, ability to breastfeed comfortably aNd
participation in newborn care will be noted to
evaluate functional outcomes. |
48 hours |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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="1"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.shashankksrivastava@gmail.com].
- For how long will this data be available start date provided 01-08-2025 and end date provided 01-08-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
In India, where cesarean section are on the rise, access to safe, effective, and affordable analgesic methods is vital. Many healthcare settings still rely heavily on systemic opioids or intrathecal morphine, which may not always be available or desirable due to their side effects, Ultrasound guided nerve blocks, TAP and QL offer reproducible, cost-effective solutions with minimal systemic effects and can be incorporated easily into postoperative protocols. This study addresses the existing gap in the literature by directly comparing the efficacy of ultrasound guided TAP versus QL block in the postoperative pain management of LSCS. |