| CTRI Number |
CTRI/2021/01/030835 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effect of anaesthetic spray in addition to local injectable anaesthesia as pain relief for scrapping the inner layer of uterus |
|
Scientific Title of Study
|
Effect of lignocaine spray in addition to paracervical block as analgesia for uterine curretage- An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramalakshmi M |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Obstetrics and Gynecology
Mahatma Gandhi Medical College and Research Institute
Pondicherry
607402
India
Mahatma Gandhi Medical College and Research Institute
Pondicherry- Cuddalore road,
Piliyarkuppam
Pondicherry-607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9629162506 |
| Fax |
|
| Email |
padma95lakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavee P |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Obstetrics and Gynecology
Mahatma Gandhi Medical College and Research Institute
Pondicherry
607402
India
Mahatma Gandhi Medical College and Research Institute
Pondicherry- Cuddalore road,
Piliyarkuppam
Pondicherry-607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9489693270 |
| Fax |
|
| Email |
pallaveep@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramalakshmi M |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Obstetrics and Gynecology
Mahatma Gandhi Medical College and Research Institute
Pondicherry
607402
India
Mahatma Gandhi Medical College and Research Institute
Pondicherry- Cuddalore road,
Piliyarkuppam
Pondicherry-607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9629162506 |
| Fax |
|
| Email |
padma95lakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and research Institute |
| Address |
Mahatma Gandhi Medical College and Research Institute
Pondicherry-Cuddalore road
Pillayarkuppam,
Pondicherry-607402
|
| 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 Ramalakshmi |
Department of obstetrics and gynecology |
Department of Obstetrics and Gynecology
Mahatma Gandhi Medical College and Research Institute
Pondicherry
607402
India
607402
Pondicherry
PONDICHERRY |
9629162506
padma95lakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% local lignocaine spray with 1% lignocaine paracervically |
10% lignocaine spray will be directed on the vaginal vault and cervical external os. Then 1% lignocaine will be injected paracervically |
| Comparator Agent |
No lignocaine spray with 1% lignocaine paracervically |
Patient will not be given local lignocaine spray before injecting 1% lignocaine paracervically |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients planned for uterine curettage procedure under paracervical block |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to lignocaine
Active genital tract infection
Past history of cervical surgery
History of chronic pelvic pain |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of lignocaine spray plus paracervical block with paracervical block alone for pain relief by
after holding the cervix with instrument
immediately after procedure
30 minutes post procedure
1 hour post procedure |
Till 1 hour post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects between the 2 groups
Compare satisfaction score between the 2 groups using 5 point likert scale |
Till 1 hour post procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/01/2021 |
| 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
|
After completing the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients fulfilling the eligibilty criteria will be included after obtaining informed consent. Detailed history, clinical examination and routine preoperative investigation will be done and patients will be allocated into group 1 and group 2.In Group 1 patients 10ml of 1% lignocaine will be injected paracervically at 5 and 7 o’ clock at the junction of cervix and vagina for Paracervical block(PCB). In Group 2 patients,3 puffs of lignocaine spray(30mg of 10% lignocaine) will be directed on cervix and vaginal vault. After a waiting period of 2 minutes cervix will be held with an instrument and another 3 puffs will be directed towards the cervical external os. After further waiting period of 2 minutes 10ml of lignocaine will be injected paracervically at 5 and 7 o’clock at the junction of cervix and vagina for PCB .After PCB patients will undergo uterine curettage procedures according to the institution protocol. Pain score will be qualified by numeric pain rating scale(NPRS) which will be explained to the patient before the procedure. NPRS will be used after holding the cervix, immediately after the procedure,30 minutes and 1 hour after the procedure. |