| CTRI Number |
CTRI/2026/01/101539 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
In this study, we will find out how putting ropivacaine directly into the wound after a caesarean section helps to reduce pain after surgery.” |
|
Scientific Title of Study
|
Effect of local wound infiltration with ropivacaine in post operative pain relief after caesarean section |
| 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 ANJU YADAV |
| Designation |
THIRD YEAR RESIDENT |
| Affiliation |
B . J . MEDICAL COLLEGE AND CIVIL HOSPITALASARWA AHMEDABAD |
| Address |
F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
8851714576 |
| Fax |
|
| Email |
anjalianjuyadav17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
PROFESSOR H G , DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
B. J. MEDICAL COLLEGE AND CIVIL HOSPITAL ASARWA AHMEDABAD |
| Address |
F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA RAVAL |
| Designation |
PROFESSOR H G , DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
B. J. MEDICAL COLLEGE AND CIVIL HOSPITAL ASARWA AHMEDABAD |
| Address |
F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT OF GUJARAT HEALTH AND FAMILY WELFARE DEPARTMENT 7TH FLOOR NEW SACHIVALAYA GANDHINAGAR 382010 GUJARAT INDIA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT OF GUJARAT |
| Address |
HEALTH AND FAMILY WELFARE DEPARTMENT 7TH FLOOR NEW SACHIVALAYA GANDHINAGAR 382010 GUJARAT INDIA |
| 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 ANJU YADAV |
1200 BED HOSPITAL |
OBSTETRIC OPERATION THEATRE 1200 BED HOSPITAL CIVIL HOSPITAL CAMPUS ASARWA AHMEDABAD
Ahmadabad
GUJARAT |
08851714576
anjalianjuyadav17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL AHMEDABAD |
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 |
LOCAL WOUND INFILTERATION OF NORMAL SALINE |
AT THE TIME OF SKIN CLOSURE NORMAL SALINE 20 ML WILL BE INFILTERATED IN SUBCUTANEOUS TISSUE. |
| Intervention |
LOCAL WOUND INFILTERATION OF ROPIVACAINE |
AT THE TIME OF SKIN CLOSURE ROPIVACAINE 0.5% TOTAL VOLUME 20ML WILL BE INFILTERATED IN SUBCUTANEOUS TISSUE. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA GRADE I AND II,ELECTIVE SURGERY |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL,ALLERGY TO LOCAL ANAESTHETIC DRUG ,PATIENT WITH PREGNANCY INDUCED HYPERTENSION , PATIENT WITH PRE EXISTING CARDIORESPIRATORY DISEASES,PATIENT WITH BLEEDING DISORDER. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE POST OPERATIVE PAIN SCORE |
POST OPERATIVE 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POSTOPERATIVE NEED OF RESCUE ANALGESIA, HEMODYNAMIC MONITORING AND COMPLICATIONS. |
POSTOPERATIVE 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
31/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE RATE OF CAESAREAN SECTION HAS BEEN ON PROGRESSIVE RISE EVER SINCE ITS ASSOCIATON WITH IMPROVED FETAL PROGNOSIS.POSTOPERATIVE PAIN AFTER CAESAREAN SECTION IS ONE OF MOST PREVENTABLE ADVERSE OUTCOME OF SURGERY. ROPIVACAINE IS A LOCAL ANAESTHETIC DRUG WHICH ACTS BY INHIBITING THE TRANSMISSION OF NOXIOUS STIMULI FROM THE SITE OF INJURY BY REVERSIBLE HYPERPOLARIZATION OF PERIPHERAL NERVE FIBERS.THIS STUDY IS TO ESTABILISH THE EFFICACY OF LOCAL WOUND INFILTERATION WITH ROPIVACAINE 0.5% AS ANALGESIC. |