| CTRI Number |
CTRI/2024/12/078360 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of 0.5 percent Hyperbaric Levobupivacaine Plain versus 0.5 percent Hyperbaric Levobupivacaine with Intrathecal Fentanyl for Spinal Anesthesia in Infra-Umbilical Surgeries |
|
Scientific Title of Study
|
A study to compare the effects of 0.5 percent Hyperbaric levobupivacaine plain vs 0.5 percent Hyperbaric levobupivacaine with intrathecal Fentanyl for spinal anaesthesia in infra umbilical surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Jaggi |
| Designation |
Resident doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor,Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8780627207 |
| Fax |
|
| Email |
tanyajaggi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Medical Superintendent |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor,Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| Designation |
Medical Superintendent |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia department, General OT complex, 2nd floor,Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Pipariya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya,
Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodiya, Pipariya, Vadodara
Pin-391760, Gujarat |
| Type of Sponsor |
Private 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 |
| Dr Tanya Jaggi |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anaesthesia Department, General OT complex, 2nd floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep
vidyapeeth Wagodhia ,
Pipariya, Vadodara
GUJARAT 391760
Vadodara
GUJARAT |
8780627207
tanyajaggi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional 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 |
| Intervention |
Hyperbaric levobupivacaine |
Dose is 0.5 percent Hyperbaric
Levobupivacaine 3ml with 0.5ml
normal saline total 3.5ml Route of
administration is intrathecal
administration. |
| Comparator Agent |
Hyperbaric levobupivacaine with Fentanyl |
Dose is 0.5 percent Hyperbaric
Levobupivacaine 3ml with fentanyl
0.5ml (25mcg) total 3.5ml Route
of administration is intrathecal
administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing to sign the written & informed consent.
2) Patients belonging to American Society of anesthesiologists grade I, II amd III
3) Patients with no history of allergy to opiods will be selected for the study.
4) Patients posted for infraumbilical surgeries. |
|
| ExclusionCriteria |
| Details |
1) Patient’s refusal from taking part in the study.
2) Patients who have used any opioid or sedative medications in the week prior to surgery
3) Patients having history of drug abuse in the past.
4) Patient who have history of allergic reactions to bupivacaine or fentanyl.
5) Patient who have contraindication to spinal anaesthesia (e.g., coagulation defects, infection at
puncture site, pre-existing neurological deficits in the lower extremities), and cardiovascular,
respiratory, neurological, psychological, hepatic, or renal disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of intrathecal fentanyl as
an adjuvant to hyperbaric 0.5 percent levobupivacaine and
hyperbaric 0.5 percent levobupivacaine alone in onset and
prolonging effects of spinal and motor block
, hemodynamic stability, effect on duration of
anaesthesia and post operative analesgia in
patients receiving spinal anaesthesia in infra
umbilical surgeries.
|
0 minute
2 minutes
4 minutes
6 minutes
8 minutes
10 minutes
20 minutes
30 minutes
40 minutes
60 minutes
90 minutes
120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess VAS Score , Duration of Absolute &
effective analgesia, number of rescue analgesia
required in 24 hrs & post operative complication
if any
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="0"
Months="6"
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
|
The purpose of the study is to compare the effects of administration of intrathecal fentanyl as an
adjuvant to intrathecal hyperbaric 0.5 percent levobupivacaine versus administration of only intrathecal Hyperbaric 0.5 percent levobupivacaine, assessing for onset, the duration of effect of spinal and motor block in spinal anesthesia , hemodynamic stability , effect on duration of anesthesia , effects on duration of analgesia and side effects if any occur.
|