| CTRI Number |
CTRI/2019/03/018103 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
14/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is being conducted to compare two methods of pain relief for cesarean section one of which involves giving an injection in the back and the other over sides of abdomen |
|
Scientific Title of Study
|
Comparative study between Erector spinae plane block and Transversus abdominis plane block for postoperative analgesia in lower segment caesarean deliveries - A randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUSHMA TK |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal Kasturba Medical College Udupi KARNATAKA 576104 India |
| Phone |
9701720077 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SUSHMA TK |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal Kasturba Medical College Udupi KARNATAKA 576104 India |
| Phone |
9701720077 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SUSHMA TK |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal Kasturba Medical College Udupi KARNATAKA 576104 India |
| Phone |
9701720077 |
| Fax |
|
| Email |
drsushmagowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College student research fund, Kasturba Medical College, MAHE, Manipal 576104, Udupi |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College student research fund |
| Address |
Kasturba Medical College Manipal |
| 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 |
| Nimmala Vinod Reddy |
Kasturba Medical College and Hospital |
Department of Anaesthesiology
Udupi KARNATAKA |
9701720077
vinodreddy.nimmala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane block |
Ultrasound guided bilateral Erector Spinae Plane block given with 20 ml of 0.2% Ropivacaine with 25mcg Dexmedetomidine on either side |
| Comparator Agent |
Transversus Abdominis Plane block |
Ultrasound guided bilateral Transversus Abdominis Plane block with 20 ml of 0.2% Ropivacaine with 25 mcg Dexmedetomidine on either side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All ASA II pregnant women in the age group of 18 to 40 years undergoing elective lower segment caesarean deliveries under subarachnoid block are included in the study |
|
| ExclusionCriteria |
| Details |
Patient refusal
Coagulation disorders
Local infection at the site of block
Allergy to study medications
BMI >35 kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Duration of analgesia (by noting down the demand for first analgesia)
b) 24 hour opioid (tramadol) consumption
|
Every hour for the first 10 hours and 24 hrs postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction score from 1 to 10 |
24hours after the surgery |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/04/2019 |
| 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="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caesarean
delivery is one of the most commonly performed surgical procedures. The
postoperative pain associated with it causes significant reduction in the
functional quality of the postpartum mother especially on the day of the
procedure. The optimum form of postoperative analgesia is not known, but many
procedures are carried out under spinal anaesthesia and patients typically
receive spinal opioids, systemic opioids as components of multimodal analgesia
in the postoperative period. However, long acting opioids, whether given via
the spinal or systemic route, are frequently associated with adverse effects
such as nausea, pruritus, sedation and occasionally respiratory depression.
Thus knowledge about the alternative (non-opioid) analgesia especially regional
techniques is important.
The regional techniques like epidural and TAP blocks
have been found to provide effective postoperative analgesia in cesarean
deliveries. ESP block is a novel technique which has found its applicability in
many truncal and hip surgeries. Also, it is believed that this technique is
technically less demanding as compared to other techniques described above |