| CTRI Number |
CTRI/2023/07/055456 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic efficacy of wound infiltration with bupivacaine versus bupivacaine and tramadol for postoperative pain relief in lower segment cesarean section under spinal anesthesia |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of wound infiltration with bupivacaine versus bupivacaine and tramadol for postoperative pain relief in lower segment cesarean section under spinal anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Jagtap |
| Designation |
Resident MD anesthesia |
| Affiliation |
DY patil medical college and research center |
| Address |
B-35 Carnation girls hostel DY patil medical college ,pimpri pune
B-35 Carnation girls hostel DY patil medical college pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9090120025 |
| Fax |
|
| Email |
pallu525252@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor MD anesthesia |
| Affiliation |
DY patil medical college and research center |
| Address |
B2 - 203 Mahindra antheia Pimpri- nehrunagar road Pimpri Pune_411018 Maharashtra
B2 - 203 Mahindra antheia Pimpri- nehrunagar road Pimpri Pune_411018 Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Jagtap |
| Designation |
Resident- MD anesthesia |
| Affiliation |
DY patil medical college and research center |
| Address |
B-35 Carnation girls hostel DY patil medical college pimpri pune
B-35 Carnation girls hostel DY patil medical college pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9090120025 |
| Fax |
|
| Email |
pallu525252@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical college and hospital |
| Address |
Dr d y patil medicalcollege pune |
| 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 |
| DrPallavi Jagtap |
DY PATIL Medical college and research center |
High tech building 5th floor OT complex DY patil medical college , pune
Pune
MAHARASHTRA |
9090120025
pallu525252@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meeting of research and recognition committee under the faculty of medicine held on 15th october,2022 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asa 1 or Asa 2 fit patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local Wound Infiltration Bupivacaine plus tramadol |
Analgesic Efficacy of Local Wound Infiltration with Bupivacaine plus Tramadol .Will receive Injection Bupivacaine 0.25% 0.7 mg/kg mixed with tramadol 2 mg/kg (diluted to 20 ml with normal saline) for Postoperative Pain Relief in Lower Segment Caesarean Section under Spinal Anaesthesia |
| Comparator Agent |
Local wound infiltration with Bupivacaine |
Analgesic Efficacy of Local Wound Infiltration with Bupivacaine 0.25% 0.7 mg/kg (diluted to 20 ml with normal saline)
for Postoperative Pain Relief in Lower Segment Caesarean Section under Spinal Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grade I or II fit patients.
1.Pregnant women age between 18 to 35 years undergoing Lower Segment Cesarian Section under spinal anesthesia.
2.Hemodynamically stable patients with all routine investigations within normallimits without any other co- morbidities. |
|
| ExclusionCriteria |
| Details |
Severe cardiopulmonary, renal or liver disease
1.Preeclampsia & Eclampsia
2.Allergy to tramadol or bupivacaine
3.Patient refusal
4.Patient with ASA Grade III or > III.
5.Patients with drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observe analgesic Efficacy of Wound Infiltration with Bupivacaine for Postoperative Pain Relief in Lower Segment Caesarean Section under Spinal Anaesthesia |
Postoperative at 2 hours,4 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe analgesic Efficacy of Wound Infiltration with Bupivacaine plus tramadol for Postoperative Pain Relief in Lower Segment Caesarean Section under Spinal Anaesthesia |
Postoperative at 2 hours, 4 hours, 6 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2023 |
| 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="6"
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
|
It is a randomized prospective comparative double blind study where in Comparison of Analgesic Efficacy of Wound Infiltration with Bupivacaine versus Bupivacaine and Tramadol for Postoperative Pain Relief in Lower Segment Caesarean Section under Spinal Anaesthesia |