| CTRI Number |
CTRI/2023/08/056732 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to compare effect of two drugs hyperbaric ropivacaine with fentanyl in Intrathecal blockade in lower limb orthopedic surgeries. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF INTRATHECAL HYPERBARIC ROPIVACAINE VERSUS HYPERBARIC ROPIVACAINE WITH FENTANYL AS ADJUVANT IN LOWER LIMB ORTHOPEDIC SURGERIES- DOUBLE BLINDED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpitha S |
| Designation |
Post Graduate , Department of Anaesthesiology. |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Anaesthesiology,
6th floor,
Yenepoya Hospital,
Deralkatte.
Department of Anaesthesiology,
6th floor,
Yenepoya Hospital,
Deralkatte.
Udupi
KARNATAKA
575018
India |
| Phone |
7026326799 |
| Fax |
|
| Email |
arpitha2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHANKARANARAYANA |
| Designation |
Professor, department of anaesthesiology |
| Affiliation |
Yenepoya medical college |
| Address |
Yenepoya medical college , university road, Deralakatte, Mangalore
Yenepoya medical college , university road, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
|
| Fax |
|
| Email |
drbhatta77@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHANKARANARAYANA |
| Designation |
Professor, department of anaesthesiology |
| Affiliation |
Yenepoya medical college |
| Address |
Department of Anaesthesiology,
6th floor,
Yenepoya medical college , university road, Deralakatte, Mangalore
Department of Anaesthesiology,
6th floor
Yenepoya medical college , university road, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
|
| Fax |
|
| Email |
drbhatta77@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARPITHA S |
| Address |
KIRTHI MOMENTO, FLAT NO 602, 6TH FLOOR, NAIRKERE ROAD, UDUPI. |
| Type of Sponsor |
Other [PERSONAL] |
|
|
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 Shankaranarayana |
Yenepoya medical college |
Department of Anaesthesiology,
6th floor,
Yenepoya Hospital,
University road , Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
9449568734
drbhatta77@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric ropivacaine 0.75% and fentanyl |
GROUP A – In this group 35 patients will be studied and will receive Inj 0.75% Ropivacaine heavy 2.5ml + Inj Fentanyl 25mcg (0.5ml).
GROUP B – In this group 35 patients will be studied and will receive Inj 0.75% Ropivacaine heavy 2.5ml + 0.5ml of normal saline. |
| Intervention |
Spinal anaesthesia |
After shifting the patient into operation theatre, monitors will be connected and baseline vitals will be recorded like heart rate, non-invasive blood pressure and oxygen saturation and documented. Intravenous access will be secured with 18G cannula under aseptic precaution and Ringer lactate fluid will be started. Subarachnoid block will be performed in sitting position using 25G Quincke’s needle at L3-L4 in median approach. Study solution will be prepared by another anaesthesiologist who will not be involved in the study. Patient will be placed supine after procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between 18-60years patients who are scheduled for lower limb orthopedic surgery under spinal anesthesia
Gender: Both Male and Female
ASA PS: I,2
|
|
| ExclusionCriteria |
| Details |
Adult patients aged between 18-60 years who are undergoing emergency lower limb orthopedic surgeries
Cardiovascular disease
Prolonged surgeries (>3hours) or if it is converted to general anaesthesia
Patients with coagulopathy
Known contraindication for spinal anesthesia.
|
|
|
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 |
| Neuraxial blockade |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) sensory blockade
2) request for first analgesia
3) hemodynamic parameters
|
24hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/09/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
PURPPOSE - Comparative study of Intrathecal hyperbaric ropivacaine versus hyperbaric ropivacaine with fentanyl as adjuvant in lower limb orthopedic surgeries.
JUSTIFICATION / NEED FOR STUDY Studies show that hyperbaric ropivacaine has safer cardiac profile compared to bupivacaine. Addition of Fentanyl will prolong the onset of blockage thus making it more hemodynamically stable.Hence we wanted to do comparative study of intrathecal hyperbaric ropivacaine versus hyperbaric ropivacaine with fentanyl as adjuvant in lower limb orthopedic surgeries on block characteristics, hemodynamic parameters,side effect profile and postoperative analgesia. AIM: is to study the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric ropivacaine for lower limb orthopedic surgeries. OBJECTIVES - To compare onset and duration of sensory and motor block , post operative analgesic effect, hemodynamic changes of intrathecal hyperbaric Ropivacaine and hyperbaric Ropivacaine with fentanyl as adjuvant. To evaluate and compare the adverse effects .
|