| CTRI Number |
CTRI/2024/11/077278 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Post operative pain relief with a combination of tramadol and ketorolac in caesarean section |
|
Scientific Title of Study
|
The efficacy of sublingual ketorolac with tramadol in post operative pain relief in cesarean cases a double blinded randomized controlled 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 |
Dr Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka mission medical college and hospital |
| Address |
Department of anaesthesiology
Vinayaka mission medical college and hospital
Keezhakasakudy Medu
Kottucherry Post
Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeniffer Karan PM |
| Designation |
Junior resident/Post Graduate |
| Affiliation |
Vinayaka mission medical college and hospital |
| Address |
Room no 2, Department of Anaesthesiology
Vinayaka mission medical college and hospital
KeezhakasakudyMedu
Kottucherry Post
Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
8056945708 |
| Fax |
|
| Email |
Jenny.pyr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhisheak Raveendran |
| Designation |
Junior resident/Post Graduate |
| Affiliation |
Vinayaka mission medical college and hospital |
| Address |
Room no 2, Department of Anaesthesiology
Vinayaka mission medical college and hospital
Keezhakasakudy Medu
Kottucherry Post
Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
9941078403 |
| Fax |
|
| Email |
rabhisheak91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka mission medical college,
Department of Anaesthesiology,
Vinayaka mission medical college and hospital,
Keezhakasakudy Medu,
Karaikal,
Pondicherry 609609. |
|
|
Primary Sponsor
|
| Name |
Vinayaka mission medical college |
| Address |
Keezhakasakudy Medu
Kottucherry Post
Puducherry 609609 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jeniffer Karan PS |
Vinayaka mission medical college |
Department of Anaesthesiology
Keezhakasakudy Medu
Kottucherry
Karaikal
PONDICHERRY |
8056945708
Jenny.pyr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Vitamin C 400mg sublingual tablet single dose administered per oral sublingually after cesarean section before shifting to Postoperative care unit |
| Intervention |
Ketrolac |
Ketrolac 10mg with Tramadol 40mg sublingual tablet single dose administered per oral sublingually after cesarean section before shifting to Postoperative care unit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients schedule to undergo elective and emergency caesarean surgery under spinal anaesthesia
Patients under ASA 1 ,ASA 2
ASA – AMERICAN SOCIETY OF ANAESTHESIA
|
|
| ExclusionCriteria |
| Details |
ASA-3ASA -4,ASA-5(ASA- AMERICAN SOCIETY OF ANAESTHESIA)
Uncontrolled systemic disorder
Contraindication to central neuraxial blockage
Neurological impairment
Demyelinating disease
Psychoactive Medications/Substance abuse
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect of the drug post operatively and subsequent need of rescue analgesic |
Until first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Presence of any adverse effects post operatively |
Until first rescue analgesia |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pain management is one of the most essential components of post operative care. Analgesic namely used are nonsteroidal anti-inflammatory Drugs (NSAIDS) and opioids. Present study aimed to compare the effect of sublingual ketorolac and tramadol on post operative pain management
Ketorolac is versatile, as it is available in multiple-dose forms: oral, nasal spray, Intravenous ,intramuscular. It is commonly used in postoperatively for pain management. The study is to compare the efficacy of sublingual ketorolac and tramadol administer after surgery with a control group
The aim of this study is to understand the efficacy of the sublingual ketorolac and tramadol role in post operative analgesic effect
|