| CTRI Number |
CTRI/2020/08/026995 [Registered on: 05/08/2020] Trial Registered Prospectively |
| Last Modified On: |
01/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of dexamethasone and dexmedetomidine to ropivacaine in ultrasound guided transverse abdominis block for postoperative pain relief in caesarean section |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided transverse abdominis block for postoperative pain relief in caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamakshi garg |
| Designation |
Associate proffessor |
| Affiliation |
Dayanand medical college and hospital ,ludhiana |
| Address |
Anaesthesia department,dayanand medical college, ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamakshi garg |
| Designation |
Associate proffessor |
| Affiliation |
Dayanand medical college and hospital ,ludhiana |
| Address |
Anaesthesia department,dayanand medical college, ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamakshi garg |
| Designation |
Associate proffessor |
| Affiliation |
Dayanand medical college and hospital ,ludhiana |
| Address |
Anaesthesia department,dayanand medical college, ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814444121 |
| Fax |
|
| Email |
drkamakshigarg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand medical college and hospital,civil lines, tagore nagar, ludhiana, punjab |
|
|
Primary Sponsor
|
| Name |
Dmch |
| Address |
Ludhiana |
| 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 |
| Nitika singla |
Dayanand medical college and hospital |
anaesthesia department , 1st floor, dayanand medical college and hospital, civil line , tagore nagar , ludhiana , punjab 141001
Ludhiana
PUNJAB |
9478171802
nitika942@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITTEE , DAYANAND MEDICAL COLLEGE, LUDHIANA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parturients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
50ml of 0.1mg/kg Dexamethasone with 3mg/kg o.75% ropivacaine versus 50 ml of 1mcg/kg Dexmedetomidine with o.75% ropivacaine |
comparison of analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided transverse abdominis block for postoperative pain relief in caesarean section |
| Intervention |
transverse abdominis block |
comparison of analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided transverse abdominis block for postoperative pain relief in caesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA-1,2,3 |
|
| ExclusionCriteria |
| Details |
Any contraindication to spinal anesthesia; history of recent opioid exposure; hypersensitivity to any drugs used in study; significant cardiovascular, renal or hepatic diseases and known fetal abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to initial postoperative pain and first rescue analgesic.
Adverse effects if any |
outcome will be assessed immediately after shifting the patient to recovery, every hrly until the patient experience pain with VAS more than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to initial rescue analgesic.
Adverse effects if any |
outcome will be assessed immediately after shifting the patient to recovery, every hrly until the patient experience pain with VAS more than 3, we will give i.m diclofenac 75mg |
|
|
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" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/08/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative caesarean patients have break through post op pain which will affects mother and baby. So we will give transverse abdominis peroneus block after completion of caesarean section with ropivacaine with dexmedetomidine or dexamethasone and compare the efficacy of dexmedetomidine versus dexamethasone as an adjunct to ropivacaine for post operative pain relief in caesarean section |