| CTRI Number |
CTRI/2022/10/046403 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
24/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of duration of analgesia Between Ropivacaine Heavy With Fentanyl and Ropivacaine Heavy with Dexmedetomidine in spinal anaesthesia for below umbilical surgeries |
|
Scientific Title of Study
|
Comparative Study Of Postoperative Analgesia After Intrathecal Ropivacaine Heavy with Fentanyl and Ropivacaine Heavy with Dexmedetomidine In Lower Abdominal Surgeries-A Randomised Controlled Trial |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUPRITA SURESH NAIK |
| Designation |
Junior resident department of anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Department of anesthesiology, vijayanagar institute of medical sciences, cantonment
Ballari
Bellary
KARNATAKA
INDIA
Bellary
KARNATAKA
583104
India |
| Phone |
8105747799 |
| Fax |
|
| Email |
supritanaik08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUPRITA SURESH NAIK |
| Designation |
Junior resident department of anesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
department of anesthesiology, vijayanagar institute of medical sciences, cantonment
Ballari
Bellary
KARNATAKA
INDIA
Bellary
KARNATAKA
583104
India |
| Phone |
8105747799 |
| Fax |
|
| Email |
supritanaik08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Devanand |
| Designation |
Professor and HOD Department of anaesthesiology |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Vijaynagar institute of medical sciences
Department of anesthesiology
Cantonment, Ballari
KARNATAKA
Bellary
KARNATAKA
583104
India |
| Phone |
9845233239 |
| Fax |
|
| Email |
dr.devanand.b@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
Vijayanagar institute of medical sciences, cantonment, Ballari, 583104 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| SUPRITA SURESH NAIK |
Vijayanagar institute of medical sciences |
Department of Anaesthesiology,Ballari Karnataka
Bellary
KARNATAKA |
8105747799
supritanaik08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine heavy Fentanyl |
Fentanyl is a lipophilic synthetic opioid and strong agonist at the mu opioid receptor and used intrathecal for subarachnoid block in a dosage of 25mcg along with Ropivacaine heavy 0.75% 2.5 ml. Total volume 3ml and observed for 3hours |
| Intervention |
Ropivacaine heavy with Dexmeditomidine |
Dexmeditomidine is selective alpha 2 agonist used INTRATHECAL for subarachnoid block in a dosage of 5mcg(in 0.5ml NS) along with Ropivacaine heavy 0.75% 2.5ml. Total volume 3ml.Given for short duration lower abdominal surgeries and observed for 3 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower abdominal surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal for spinal anaesthesia
History of allergy to drugs
Any contraindication for spinal anaesthesia
Deformity of lumbosacral spine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Less postoperative analgesia required |
From intrathecal administration of drug till two segment regression |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of sensory blockade
Onset of motor blockade
Duration of sensory blockade
Duration of motor blockade
Intraoperative and postoperative hemodynamics
Intraoperative and postoperative sedation score |
Inta and postoperative for 2hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/10/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is widely used technique for infra umbilical surgeries providing fast onset and effective sensory and motor blockade and prolonged postoperative analgesia.spinal hyperbaric Ropivacaine may produce more reliable and predictable anaesthesia than plain Ropivacaine. Among the various adjuvants added to intrathecal spinal anaesthesia Dexmedetomidine and Fentanyl are commonly used. Recently hyperbaric Ropivacaine is being introduced into the clinical practice and there is a dearth in literature regarding use of hyperbaric Ropivacaine for subarachnoid block. Hence this study is designed to investigate and compare the effects of Hyperbaric Ropivacaine with additives such as Fentanyl and Dexmedetomidine on spinal anaesthesia. |