| CTRI Number |
CTRI/2021/08/035932 [Registered on: 25/08/2021] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia
|
|
Scientific Title of Study
|
Effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia
: a randomised controlled study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lairikyengbam Sheityajit Roy |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
7005155846 |
| Fax |
|
| Email |
thoithoi2402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N Ratan Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9436027270 |
| Fax |
|
| Email |
drnratansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr N Ratan Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
9436027270 |
| Fax |
|
| Email |
drnratansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal, Manipur-795004 |
|
|
Primary Sponsor
|
| Name |
Lairikyengbam Sheityajit Roy |
| Address |
Post Graduate Trainee, Regional Institute of Medical Sciences, Imphal, Manipur-795004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Lairikyengbam Sheityajit Roy |
Regional Institute of Medical Sciences, Imphal |
Operation Theatre complex ,Department of Anesthesiology
Imphal West
MANIPUR |
7005155846
thoithoi2402@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal (hyperbaric bupivacaine with fentanyl citrate) |
2ml 0.5% hyperbaric bupivacaine with 0.5ml (12.5 mcg) fentanyl citrate |
| Comparator Agent |
Intrathecal (hyperbaric bupivacaine with fentanyl citrate) |
2ml 0.5% hyperbaric bupivacaine with 0.5ml(25 mcg) fentanyl citrate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
(ASA) physical status I or II undergoing lower segment caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. History of allergy to study drugs
2. Bleeding disorder-platelet count
<50,000/micro litre, prothrombin
time>14sec,International normalised
ratio(INR)->1.5
3. Local site infection
4. Cardiac, respiratory diseases and
kidney disorder, neurological deficit
5. Spinal deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia [Time (minutes) to demand of first rescue analgesic assessed by visual analogue scale] |
From time of intrathecal injection (baseline) to the time when patient first demands rescue analgesia (minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Oxygen saturation (SpO2)
2. Time of sensory block at onset T 10(secs)
3. Maximum sensory level achieved
4. Time to achieve maximum sensory level(secs)
5. Time to complete motor blockade(secs)
6. Time to two segment regression(mins)
7. Time to sensory regression to S2(mins)
8. Side effects
|
1. Hemodynamic profiles will be assessed at baseline, every 2 minutes till 10 minutes and then every 5 mins till the end of surgery.
2. The various time intervals will be assessed just after the intrathecal injection and then every 2 mins along the mid -clavicular line, bilaterally till the desired effect/ regression were achieved(sec/mins). The maximum sensory level achieved was also assessed in the mid -clavicular line bilaterally. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2021 |
| 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="6"
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
|
The study is a prospective randomized
double-blinded trial to assess and compare the effects of intrathecal
administration of low dose 12.5µgm and conventional
25µgm fentanyl citrate with 0.5% bupivacaine (2 ml, heavy) in parturient
undergoing LSCS procedures under subarachnoid block which will be conducted in the Department of Anaesthesiology, regional Institute of Medical Sciences, Imphal, Manipur. A
total of 60 parturient will be selected for the study and divided into 2 groups
of 30 patients each viz. Group A (n-30) and Group B (n-30) .According to a computer generated randomization
table, patients in group A will be administered 2 ml of 0.5% bupivacaine heavy
plus 0.5ml (12.5µgm) fentanyl citrate and group B will
be administered 2 ml of 0.5% bupivacaine heavy plus 0.5ml (25 µgm) fentanyl citrate in the subarachnoid space
L3-L4 In both the groups,
the study drugs will be administered at a rate of 0.2 ml/min. in the
subarachnoid space L3-L4. The time to first rescue analgesia, block
characteristics along with regression of the blockade, side effects (if any)
and the hemodynamic changes will be observed, assessed and recorded by blinded
investigator using the VAS, sedation scale, modified Bromage scale.The data collected will be collected and analysed
using Student‘t’ test for continuous
data and Chi-square test for categorical data as and where appropriate. |