| CTRI Number |
CTRI/2014/07/004789 [Registered on: 31/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO COMPARE THE EFFECT OF THREE GROUPS OF DRUGS WHEN INJECTED AT THE SITE OF SURGERY TO REDUCE POST OPERATIVE PAIN |
|
Scientific Title of Study
|
COMPARISON AMONG ROPIVACAINE 0.5%, ROPIVACAINE 0.25% AND BUPIVACAINE 0.25% FOR LOCAL INFILTRATION IN INGUINAL HERNIA REPAIR UNDER GA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASWINI L |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JIPMER PUDUCHERRY 605006
PLOT NO 1 AND 2
POOTHURAI ROAD
SIVAJI NAGAR
GORIMEDU
PUDUCHERRY.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442011352 |
| Fax |
- |
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMAN LATA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JIPMER |
| Address |
DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JIPMER PUDUCHERRY 605006
DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JIPMER PUDUCHERRY 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488830091 |
| Fax |
- |
| Email |
sumanlata13@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASWINI L |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JIPMER PUDUCHERRY 605006
PLOT NO 1 AND 2
POOTHURAI ROAD
SIVAJI NAGAR
GORIMEDU
PUDUCHERRY.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442011352 |
| Fax |
- |
| Email |
aswinijipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
JIPMER HOSPITAL,
DHANVANTRI NAGAR,
GORIMEDU,
PUDUCHERRY 605006. |
| 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 |
| DR ASWINI L DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE JIPMER PUDUCHERRY |
DEPT.OF ANAESTHESIOLOGY, 2ND FLOOR,OLD BUILDING,JIPMER HOSPITAL, PONDICHERRY |
JIPMER HOSPITAL,
DHANVANTRI NAGAR,
GORIMEDU,
PUDUCHERRY.
PUDUCHERRY 605006
Pondicherry
PONDICHERRY |
9442011352
-
aswinijipmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES), JIPMER, PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
UNDERGOING INGUINAL HERNIA REPAIR, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPIVACAINE 0.25% |
20 ml of bupivacaine 0.25% used as control for local infiltration at the surgical site into the fascia. |
| Intervention |
ROPIVACAINE 0.25% |
Ropivacaine 0.25% 20 ml is used as an interventional agent , for local infiltration at the surgical site into the fascia. |
| Intervention |
ROPIVACAINE 0.5% |
Ropivacaine 0.5% 20 ml is used as an intervention agent, for local infiltration at the surgical site into the fascia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA physical status I and II and those between the age groups 18 to 70, undergoing elective inguinal hernia repair under general anaesthesia were included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with a known allergy to local anasethetics and those who refused to give consent were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE PAIN SCORE |
EVERY ONE HOUR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| POST OPERATIVE ANALGESIC REQUIREMENTS |
EVERY ONE HOUR |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was performed to compare the analgesic properties of ropivacaine and bupivacaine in different concentrations ropivacaine 0.5%, ropivacaine 0.25% and bupivacaine 0.25%. The drugs in three different concentrations were used for local infiltration in inguinal hernia repair. Intra operatively heart rate, blood pressure were compared between the three groups. Post operatively pain scores were assessed using VAS scores. The time for rescue analgesia was noted in each group. It was found tat Ropivacaine 0.5% was as potent as bupivacaine 0.25%. Pain scores were lesser in these two groups. Time for rescue analgesia was shorter in ropivacaine 0.25% group. Study ended with the first request of rescue analgesia. |