| CTRI Number |
CTRI/2020/04/024687 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Transverse abdominis plane block usg guided with dexamethasone for enhanced post operative pain relief in post operative lscs patients |
|
Scientific Title of Study
|
Analgesic efficacy of Inj. Dexamethasone as an adjuvant with
Inj Levobupivacaine in ultrasound guided transverse abdominis plane (TAP) block after caesarean delivery- A prospective randomized controlled double blind study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumud S Ganvit |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumud S Ganvit |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumud S Ganvit |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Baroda medical college, Vinobha bhave road, Anandpura, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baroda Medical College and SSG Hospital, Vadodara |
|
|
Primary Sponsor
|
| Name |
SSG Hospital |
| Address |
Department of Anaesthesiology, Baroda Medical College and SSG Hospital, Vinoba Bhave road, Anandpura, Vadodara |
| 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 Erra Shirish |
SSG Hospital and Baroda Medical College |
Department of Anaesthesiology, Baroda Medical College and SSG Hospital, Vinoba Bhave road, Anandpura, Vadodara
Vadodara
GUJARAT |
9581864868
drshirish@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR-PGR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Dexamethasone 8mg(2cc) |
Inj. Dexamethasone (8mg) added to Inj. Levobupivacaine 0.25% 30ml for usg guided TAP block. Total of 32ml [16ml on each side].It is a tissue plane block and the average duration of pain relief is to be noted |
| Comparator Agent |
sterile water |
sterile used as control drug added to Inj. levobupivacaine for usg guided TAP block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) singleton ,full term pregnancy
2) ASA Physical status – I or II
3) scheduled for elective and emergency LSCS under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1) Patients refusal and not able to understand study protocol.
2) Patients who are hypersensitivity to local anaesthetic drug.
3) Contraindication to spinal anaesthesia.
4) Severe PIH
5) Patients with compromised renal and liver function, uncontrolled diabetes severe cardiovascular and respiratory disease.
6) Infection, trauma, scar or sinuses at site of TAP block |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to first rescue analgesia (Vas score 4) between the two groups. |
VAS Score at 2,4,6,8,12,18 and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the total amount of rescue analgesia required in first 24 h post operatively.
|
After 24 hrs of giving TAP block |
| Hemodynamic parameter in both groups. [PR, BP, SPO2] post block |
Baseline (just after shifted to USG room)
During procedure
At 15,30,45, and 60minute.
At 2,4,6,8,12,18,24hour |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| 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
|
Our goal is to evaluate the analgesic efficacy of Inj. Dexamethasone as adjuvant with Inj. Levobupivacaine as local anaesthetic in ultra sound guided transversus abdominis plane (TAP) block in post cesarean delivery conducted under spinal anaesthesia .Our primary objective is to compare the time to first rescue analgesia between the two groups determines by VAS (visual analogue scale) score of more than 4. |