| CTRI Number |
CTRI/2025/05/086392 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
PARTICIPANTS ARE ELECTIVE GYNECOLOGICALPROCEDURES which will be done in spinal anaesthesia
we used to compare two drug component
one group will receive ropivacaine alone and another group will receive ropivacaine with adjuvant fentanyl
ropivacaine is more cardiostable as compare to bupivacaine
|
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED TRIAL TO COMPARE 0.75 PERCENTAGE HYPERBARIC ROPIVACAINE ALONE VERSUS 0.75 PERCENTAGE HYPERBARIC ROPIVACAINE WITH ADJUVANT FENTANYL FOR GYNECOLOGICAL SURGERIES UNDER SPINAL ANAESTHESIA |
| Trial Acronym |
hyperbaric ropivacaine with adjuvant fentanyl versus hyperbaric ropivacaine alone in gynaecological surgeries |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak dineshbhai sitapara |
| Designation |
3rd year resident |
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9638037632 |
| Fax |
|
| Email |
palaksitapara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Palak dineshbhai sitapara |
| Designation |
|
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9638037632 |
| Fax |
|
| Email |
palaksitapara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palak dineshbhai sitapara |
| Designation |
3rd year resident |
| Affiliation |
GCS medical college, hospital and research centre |
| Address |
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9638037632 |
| Fax |
|
| Email |
palaksitapara@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Palak dineshbhai sitapara self |
| Address |
anaesthesia department, GCS medical college , hospital and research centre, near Chamunda bridge , naroda road , ahmedabad -380025
Gujarat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Divya Kheskani |
25 balgayatri society part1
opp gokul raw house
shyamal
satellite |
| Dr Heena Channwal |
motera
ahmedabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPalak Sitapara |
GCS Medical college, hospital and research centre |
anaesthesia department, OT no 4 , gynaecological operation theatre
Ahmadabad
GUJARAT |
9638037632
palaksitapara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECGCSMCH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N800||Endometriosis of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group R 0.75% hyperbaric ropivacaine 3 ml with 0.5 ml normal saline
group RF 0.75% hyperbaric ropivacaine 3 ml with 25mcg fentanyl |
used to compare sensory and motor onset and regression
total duration of analgesia
NRS score |
| Intervention |
spinal anaesthesia in elective gynecological surgeries |
spinal anaesthesia with two different drug group
and compare 0.75% hyperbaric ropivacaine alone with 0.75% hyperbaric ropivacaine and fentanyl as an adjuvant
total duration of intervention is 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
elective gynecological surgeries
informed and written consent |
|
| ExclusionCriteria |
| Details |
refusal of patients
local site lumbar infection
spine deformities
coagulopathies
major systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to observe time to onset and duration of sensory and motor blockade
NRS for post operative pain |
after spinal anesthesia every 2 mins then every 5 min and every 19 min then every 30 mins and half hourly for 12 hours of spinal ananesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to observehemodynamics
perioperative
to observe duration of postoperative analgesia
to observe perioperative any side effects & complications |
at baseline, every 5 mins then every 10 min,every 30 mins till 12 hours of spinal anaesthesia |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
we conducted a prospective randomised controlled trial of 100 patient of ASA grade 1 & 2 posted for elective gynecological surgeries under spinal anaesthesia. Group R receives 0.75% hyperbaic ropivacaine heavy 3 ml + 0.5 ml normal saline and Group RF receives 0.75% hyperbaric ropivacaine 3 ml + 25 mcg fentanyl. we compare the analgesic and anaesthetic efficacy in these two group. |