| CTRI Number |
CTRI/2024/01/061502 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on the block characteristics in spinal anaesthesia with premixed or sequential administration of bupivacaine(anawin) heavy and fentanyl in LSCS operation |
|
Scientific Title of Study
|
A comparative study on the block characteristics in spinal anaesthesia with premixed or succedent administration of hyperbaric bupivacaine and fentanyl in lower segment caesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BIDYA NGANGOM |
| Designation |
ANAESTHESIOLOGY PG STUDENT |
| Affiliation |
Regional institute of medical sciences IMPHAL |
| Address |
RIMS ANAESTHESIOLOGY DEPARTMENT IMPHAL
Imphal West
MANIPUR
795001
India |
| Phone |
9366131748 |
| Fax |
|
| Email |
Bidyangangom80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N RATAN SINGH |
| Designation |
PROFESSOR ANAESTHESIOLOGY |
| Affiliation |
Regional institute of medical sciences IMPHAL |
| Address |
RIMS ANAESTHESIOLOGY DEPARTMENT IMPHAL
Staff quarter RIMS imphal
Imphal West
MANIPUR
795001
India |
| Phone |
9436027270 |
| Fax |
|
| Email |
Drnratansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BIDYA NGANGOM |
| Designation |
ANAESTHESIOLOGY PG STUDENT |
| Affiliation |
Regional institute of medical sciences IMPHAL |
| Address |
RIMS ANAESTHESIOLOGY DEPARTMENT IMPHAL
Imphal West
MANIPUR
795001
India |
| Phone |
9366131748 |
| Fax |
|
| Email |
Bidyangangom80@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY RIMS IMPHAL |
|
|
Primary Sponsor
|
| Name |
BIDYA NGANGOM |
| Address |
RIMS ANAESTHESIOLOGY DEPARTMENT IMPHAL |
| Type of Sponsor |
Other [POST GRADUATE TRAINING] |
|
|
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 |
| BIDYA NGANGOM |
RIMS IMPHAL MANIPUR |
ELECTIVE ANTENATAL OPERATION THEATRE (OT2) DEPARTMENT OF ANAESTHESIOLOGY REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL
Imphal West
MANIPUR |
09366131748
Bidyangangom80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS 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, (2) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (3) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADMINISTRATION OF HYPERBARIC BUPIVACAINE IN A 5ml SYRINGE FOLLOWED SUCCEDENTLY BY ADMINISTRATION OF FENTANYL CITRATE IN A 2ml SYRINGE IN LOWER SEGMENT CAESAREAN SECTION |
ACCORDING TO RANDOMISATION BLOCKS, PATIENTS IN GROUP B WILL BE ADMINISTERED 2ml of 0.5% BUPIVACAINE HEAVY IN A 5ml SYRINGE FOLLOWED BY 0.5 ml (25mcg) FENTANYL CITRATE IN A 2ml SYRINGE IN THE SUBARACHNOID SPACE AT L3- L4 LEVEL |
| Intervention |
ADMINISTRATION OF PREMIXED HYPERBARIC BUPIVACAINE PLUS FENTANYL CITRATE WITH A 5ml SYRINGE IN LOWER SEGMENT CAESAREAN SECTION |
ACCORDING TO RANDOMISATION BLOCKS, PATIENTS IN GROUP A WILL BE ADMINISTERED PREMIXED 2ml of 0.5% BUPIVACAINE HEAVY PLUS 0.5ml (25 mcg) FENTANYL CITRATE WITH A 5ml SYRINGE IN THE SUBARACHNOID SPACE at L3-L4 LEVEL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
PARTURIENT WITH AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) I OR II AGED 18-45 YEARS UNDERGOING LOWER SEGMENT CAESAREAN SECTION UNDER SPINAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
a) HISTORY OF ALLERGY TO STUDY DRUGS
b) BLEEDING DISORDER- PLATELET COUNT -<50,000/MICROLITRE, PROTHROMBIN TIME>14 SEC, INR >1.5
c) LOCAL SITE INFECTION
d) CARDIAC,RESPIRATORY DISEASES AND KIDNEY DISORDER, NEUROLOGICAL DEFICIT
d) SPINAL DEFORMITY |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA (time to demand of first rescue analgesia assessed by visual analogue scale) |
Time (in minutes) to demand of first rescue analgesia assessed by visual analogue scale (VAS score more than 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)HAEMODYNAMIC PROFILE-SBP,DBP,MAP,SPO2
2)SENSORY BLOCK ONSET AT T10
3) MAXIMUM SENSORY LEVEL ACHIEVED
4) MAXIMUM SENSORY BLOCK LEVEL (secs)
5) COMPLETE MOTOR BLOCKADE (secs)
6) TWO SEGMENT REGRESSION OF BLOCK (mins)
7) SIDE EFFECTS SUCH AS SEDATION, ANXIETY, PRURITUS, NAUSEA, VOMITING |
1) Perioperatively at 0 min, 2 min, 4 min, 6 min, 8 min , 10 min, 15 min, 20 min, 30 min ,40 min, 50 min, till end of ot
2) TIME TO SENSORY BLOCK ONSET AT T10 ( in secs)
3)AT OR ABOVE T4 DERMATOMAL LEVELS
4) TIME TO ACHIEVE MAXIMUM SENSORY LEVEL (secs)
5) TIME TO COMPLETE MOTOR BLOCKADE - MODIFIED BROMAGE SCORE OF 3 (secs)
6) TIME TO TWO SEGMENT REGRESSION (mins)
7) ANYTIME INTRAOPERATIVELY |
|
|
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)
|
20/01/2024 |
| 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="1"
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
|
The study will be a prospective randomized double blinded study to assess and compare the effects of premixed or succedent intrathecal administration of 25 mcg fentanyl citrate with 0.5% bupivacaine (2ml , heavy) in parturient undergoing LSCS procedures under subarachnoid block.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 block randomization, patients in group A will be administered premixed 2ml of 0.5% bupivacaine heavy plus 0.5 ml (25mcg) fentanyl citrate with a 5 ml syringe and group B will be administered 2ml of 0.5% bupivacaine heavy in a 5ml syringe followed by 0.5 ml (25mcg) fentanyl citrate with a 2ml syringe in the subarachnoid space L3-L4. in both the groups, the study drugs will be administered at a rate of 0.2ml/min. The 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 modified bromage scale, VAS, sedation scale.
The data collected will be collected and analyzed using student t test for continuous data and chi square test for categorical data as and where appropriate. |