| CTRI Number |
CTRI/2025/02/079923 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ropivacaine versus Lignocaine as local anaesthetic in episiotomy |
|
Scientific Title of Study
|
The efficacy and safety of Ropivacaine in comparison to Lignocaine for perineal pain relief after Episiotomy - A double blind 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 Manasa T K |
| Designation |
Junior Resident , Dept . of Obstetrics and Gynaecology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology , AIIMS Jodhpur , Basni , Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9482634242 |
| Fax |
|
| Email |
manasatk17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Gothwal |
| Designation |
Additional professor,Dept . of Obstetrics and Gynaecology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology, AIIMS Jodhpur , Basni , Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9212126860 |
| Fax |
|
| Email |
meenakshigothwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasa T K |
| Designation |
Junior Resident , Dept . of Obstetrics and Gynaecology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology, AIIMS Jodhpur , Basni , Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9482634242 |
| Fax |
|
| Email |
manasatk17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manasa T K |
| Address |
Department of Obstetrics and Gynecology, AIIMS Jodhpur , Basni , Jodhpur ,Rajasthan 342005 |
| 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 Manasa T K |
AIIMS Jodhpur |
Department of Obstetrics and Gynaecology , AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9482634242
manasatk17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( AIIMS JODHPUR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection 0.75% Ropivacaine |
Injection 0.75% Ropivacaine used as a local anaesthetic in Episiotomy wound resuturing for perineal pain relief administered 10-15 mins before episiotomy and monitored over 24 hours |
| Comparator Agent |
Injection 1% Lignocaine |
Injection 1% Lignocaine used as a local anaesthetic in Episiotomy wound resuturing for perineal pain relief administered 10-15 mins before episiotomy and monitored over 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant females delivered by vaginal route requiring episiotomy ( mediolateral type) |
|
| ExclusionCriteria |
| Details |
Antenatal females not willing to participate in the study.
2. Allergy to local anaesthetics agents or Ropivacaine
3. Those who received epidural analgesia in labour.
4. 3rd degree perineal tear/ complete perineal tear (CPT).
5. Instrumental delivery.
6. Third stage complications like uterine inversion, PPH. |
|
|
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 |
| To compare the requirement of extra analgesia in both groups upto 6 hours after episiotomy |
To compare the requirement of extra analgesia in both groups upto 6 hours after episiotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the visual analogue scale (VAS) score immediately after suturing, 6hrs & 24 hours after episiotomy repair, comparing Lignocaine 1% & Ropivacaine
0.75% as a local anaesthetic
2. To study the satisfaction level of patients after 24 hours with ‘Ropivacaine –’ Vs
‘lignocaine’ injection during perineal repair following vaginal birth using 5 point LIKERT scale.
3. To study any side effects of Ropivacaine & any voiding difficulties till 6 hours
of episiotomy repair |
1. VAS score (VAS) score to be seen immediately after suturing, 6hrs & 24 hours after episiotomy repair
2. satisfaction level of patients after 24 hours of repair
3. side effects of Ropivacaine & any voiding difficulties till 6 hours post repair |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/02/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
SUMMARY Normal labour is the most common and expected mode of delivery, which is sometimes complicated by perineal tears associated with few complications. Episiotomy is given during 2nd stage of labour to prevent serious tears to the perineum, but one has to go through much pain when an episiotomy is given and also during its repair. So, various methods have been applied to reduce the pain caused by episiotomy, including the injection of local anaesthetics. Traditionally, Lignocaine has been used as a local anaesthetic for repairing episiotomy. Similarly, Ropivacaine, which belongs to the same class of local anaesthetics as lignocaine, has diverse uses and a wide safety margin with good antinociceptive action. It is also a cost-effective drug. The study aims to compare the analgesic efficacy and maternal satisfaction with lignocaine 1% versus Ropivacaine 0.75% infiltration for postpartum perineal pain management. |