| CTRI Number |
CTRI/2021/06/034221 [Registered on: 14/06/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| 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
|
A clinical trial to compare two different types of abdominal wall blocks in providing post-operative pain relief after cesarean section |
|
Scientific Title of Study
|
Comparison of ultrasound guided transversalis fascia and transversus abdominis plane blocks for post-operative analgesia following lower segment cesarean section- A double blinded randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGMCRI/Res/01/2020/09/ IHEC/277 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G JANANI |
| Designation |
POSTGRADUATE |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SECOND FLOOR
HOSPITAL BLOCK MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY PILLAIYARKUPPAM
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8110876679 |
| Fax |
04132615457 |
| Email |
drjanani110593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R SRIPRIYA |
| Designation |
PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SECOND FLOOR
HOSPITAL BLOCK MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY PILLAIYARKUPPAM
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9365815939 |
| Fax |
04132615457 |
| Email |
docsripriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R SRIPRIYA |
| Designation |
PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SECOND FLOOR
HOSPITAL BLOCK MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE SBV UNIVERSITY PILLAIYARKUPPAM
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9365815939 |
| Fax |
04132615457 |
| Email |
docsripriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Mahatma Gandhi Medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical college and Research Institute |
| Address |
Second floor Hospital block Mahatma Gandhi Medical college and Research Institute Pillaiyarkuppam Pondicherry - 607402 |
| 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 |
| G JANANI |
Mahatma Gandhi Medical College and Research Institute |
First and Second floor
Operation Theatre block
Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam
Pondicherry - 607402
Pondicherry
PONDICHERRY |
8110876679
drjanani110593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee of Mahatma Gandhi Medical college and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
In this group no blocks will be given at the end of cesarean section |
| Intervention |
Transversalis fascia plane block |
Transversalis fascia plane block will be given at the end of cesarean section with 20 ml of 0.25 % bupivacaine on either side of the abdomen |
| Intervention |
Transversus Abdominis plane block |
Transversus Abdominis plane block will be given at the end of cesarean section with 20 ml of 0.25 % bupivacaine on either side of the abdomen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 to 45 years, ASA II and III patients, BMI- 18-35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Allergy to local anaesthetic drugs, seizure disorder, if any intra-operative surgical complications, Prolonged duration of labour, if cesarean section is done under general anaesthesia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the static and dynamic pain scores post-operatively |
Static and dynamic pain scores will be assessed post-operatively for 24 hours at regular time intervals by asking the patient to flex their legs and by turning to one side |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of block dynamics |
Loss of sensation to touch and cold will be assessed from T10 to L4 dermatomal levels |
| Time to first analgesic requirement |
Patients will be given analgesic when they give a pain score of more than 3
The time from when the block was given to the time when the first analgesic is given will be noted as the duration of analgesia |
| Measurement of 24 hour cumulative rescue analgesic consumption |
After administering the first analgesic, even after 30 minutes if the pain continues to persist then the second rescue analgesic will be administered and the 24 hour cumulative analgesic consumption will be noted |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cesarean section is one of the most commonly performed lower abdominal surgeries. Cesarean section pain has both somatic and dynamic components. Blocking both the components helps in reducing maternal morbidity, early mobilization and increased patient satisfaction.
The infra-umbilical of the anterior abdominal is supplied by T7- L1 nerves which travel in the Transversus abdominis plane (TAP). These nerves give lateral cutaneous branches which are blocked by posterior TAP (P-TAP) block. The lateral cutaneous branch of T 12 is spared in P-TAP but blocked in Transversalis fascia plane (TFP) block. Both the blocks have been studied and found useful in decreasing the opioid requirement.
This study will be started after obtaining institutional ethics committee approval and CTRI registration. Patients undergoing cesarean section under spinal anaesthesia in MGMCRI will form the study population. 90 patients will be sampled by continuous sampling and will be allocated into groups by permuted block randomisation.
Group 1: P-TAP block will receive 20 ml of 0.25% bupivacaine on either side in TAP Group 2: TFP block will receive 20 ml of 0.25% bupivacaine on either side in TFP Group 3: No intervention - will not receive any block All patients will be given Inj. Paracetamol 1gm IV at the end of surgery and T. Paracetamol 650mg will be given at 6 hourly intervals for baseline analgesia
Static and dynamic pain scores will be assessed post-operatively for 24 hours and analgesic will be given when the dynamic score is more than 3. The time to first analgesic requirement, loss of sensation to touch and cold from T 10 to L4 dermatomes, the total 24 hour analgesic consumption will be noted. |