| CTRI Number |
CTRI/2024/10/075655 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effectiveness of transverse abdominis plane (tap) block in reducing the requirement for postoperative intravenous analgesics after cesarean section under spinal anesthesia |
|
Scientific Title of Study
|
The effectiveness of transverse abdominis plane (tap) block in reducing the need for postop analgesics after c-section under spinal anesthesia: a randomised control 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 |
Mathew George |
| Designation |
Assistant Professor |
| Affiliation |
Al Azhar Medical College and Super Speciality Hospital |
| Address |
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Padinjattil house
Pothanicad p.o
Kothamangalam
Ernakulam
686671
Idukki
KERALA
685605
India |
| Phone |
8892715040 |
| Fax |
|
| Email |
mathewp94.mg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mathew George |
| Designation |
Assistant Professor |
| Affiliation |
Al Azhar Medical College and Super Speciality Hospital |
| Address |
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Padinjattil house
Pothanicad p.o
Kothamangalam
Ernakulam
686671
Idukki
KERALA
685605
India |
| Phone |
8892715040 |
| Fax |
|
| Email |
mathewp94.mg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mathew George |
| Designation |
Assistant Professor |
| Affiliation |
Al Azhar Medical College and Super Speciality Hospital |
| Address |
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Padinjattil house
Pothanicad p.o
Kothamangalam
Ernakulam
686671
Idukki
KERALA
685605
India |
| Phone |
8892715040 |
| Fax |
|
| Email |
mathewp94.mg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605 |
|
|
Primary Sponsor
|
| Name |
Al Azhar Medical College and Super Speciality Hospital |
| Address |
Room no : 20
Division 1
Department of Anaesthesiology
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605 |
| Type of Sponsor |
Private 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 Mathew George |
Al Azhar Mediacal College and Super Speciality Hospital |
Room no : 20
Division 1
Department of anaesthesiologist
Al Azhar Medical College and Super Speciality Hospital
Thodupuzha
Idukki
Kerala
India
685605
Idukki
KERALA |
8892715040
mathewp94.mg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AL AZHAR MEDICAL COLLEGE AND SUPER SPECIALITY HOSPITAL-INSTITUTIONAL ETHICS COMMITTEE |
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 |
Intravenous analgesics agents |
Intravenous diclofenac 50 mg given every 8th hourly.
Intravenous injection paracetamol 1gram given every 8th hourly.Rescue doses with injection tramadol 50 mg when ever visual analogue scale more than 4. Patient satisfaction evaluated after 24 hour. |
| Intervention |
Transverse abdominus plane block |
Usg guided tap block is given after cesarean section with 0.2 % ropivacaine 20 ml on each side. 23 gauge spinal needle under usg guidance is used for procedure. Procedure is done in 5- 10 minutes. Patient satisfaction evaluated after 24 hours. Intravenous diclofenac 50 mg given every 8th hourly.
Intravenous injection paracetamol 1gram given every 8th hourly. Rescue doses with injection tramadol 50 mg when ever visual analogue scale more than 4. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status II
Term pregnancies of Gestational age between 37 to 42 weeks, with a singleton foetus undergoing caesarean section delivery done under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Body mass index more than 35
anatomic conditions that may preclude the regional block
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the amount of analgesic requirement after cesarean section |
48 hours after cesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction with anaesthesia among both the groups |
48 hours after cesarean section |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/11/2024 |
| 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
|
A significant number of women who have caesarean section experiences moderate-to-severe postoperative pain especially around 6 hours after delivery. Transversus abdominis plane (TAP) block is a regional anesthesia technique in which a local anesthetic is injected into the transversus abdominis (TA) plane Aim of the study is to determine the effectiveness of transverse abdominis plane (tap) block in reducing the amount of analgesics required during the first 48 hours after c-section under spinal anesthesia. Investigator and patient blinded randomized control trial. The sample size for the present study was calculated to be 44. All eligible patients undergoing caesarean section delivery under spinal anaesthesia at will be included after taking informed consent.Patients will be classified into two groups using block randomization. Group A : TAP block will be done using USG guidance. Postoperative analgesia will be provided with IV DICLOFENAC( 50 mg IV) q8h and PARACETAMOL 1000 mg q8h. Rescue doses with analgesics will be allowed (TRAMADOL 50 mg) when VAS score is >4 Group B: Standard systemic intravenous postoperative analgesia IV DICLOFENAC( 50 mg IV) q8h and PARACETAMOL 1000 mg q8h will be given. Rescue doses with analgesics will be allowed (TRAMADOL 50 mg) when VAS score is >4. Result values will be recorded using a proforma. Visual analogue scale needs to be recorded immediately on shifting to recovery and then at 2hr, 6 hr, 12 hr, 24 hr, and 48 hr both at rest and during voluntary contraction of abdominal muscles. Time at which first rescue analgesic is given to be noted. Requirement of rescue analgesics in the first 48 hrs postoperatively and presence of PONV and drowsiness is also assessed. |