| CTRI Number |
CTRI/2021/01/030366 [Registered on: 11/01/2021] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of levobupivacaine with or without dexamethasone for spinal block |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of levobupivacaine and levobupivacaine with dexamethasone in lower abdominal surgeries under subarachnoid block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RS Rautela |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Room No. 531B
Department of Anaesthesiology
UCMS and GTB Hospital
Dilshad Garden
Delhi
North East
DELHI
110095
India |
| Phone |
9625900699 |
| Fax |
|
| Email |
rsramb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RS Rautela |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Room No. 531B
Department of Anaesthesiology
UCMS and GTB Hospital
Dilshad Garden
Delhi
North East
DELHI
110095
India |
| Phone |
9625900699 |
| Fax |
|
| Email |
rsramb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachit Singhal |
| Designation |
PG student |
| Affiliation |
University College of Medical Sciences, Delhi |
| Address |
Main ICU
Second Floor
UCMS and GTBH
Delhi
North
DELHI
110085
India |
| Phone |
9560939562 |
| Fax |
|
| Email |
rachitdr08@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Guru Teg Bahadur Hospital |
| Address |
Room No 531B
Department of Anaesthesiology
Guru Teg Bahadur Hospital
Dilshad Garden
Delhi |
| 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 |
| Dr RS Rautela |
Guru Teg Bahadur Hospital |
Room NO 531B
Department of Anaesthesiology
UCMS and GTBH
Dilshad Garden
Delhi
North East
DELHI |
9625900699
rsramb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subarachnoid block |
12.5 mg of 0.5% isobaric levobupivacaine (2.5 ml) + dexamethasone 4mg (1ml) |
| Comparator Agent |
Subarachnoid block |
12.5 mg of 0.5% isobaric levobupivacaine (2.5 ml) + normal saline(1ml) will be given for subarachnoid block |
| Intervention |
Subarachnoid Block |
Subarachnoid block will be given
Block characteristics will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II
18-65 years
height 150-180 cm |
|
| ExclusionCriteria |
| Details |
Non-consenting for subarachnoid block
Infection at injection site
Coagulopathy
Space occupying lesion
Increased intracranial tension
Seizure disorder, pre-existing neurological deficit, any spine deformity
Hepatic and renal disease
On antiarrhythmics
Drug addicts and chronic alcoholic
Pre-existing diabetes mellitus
|
|
|
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 |
| Duration of effective analgesia |
6hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of sensory block.
Quality of motor block.
|
every 5 minutes for first 30 minutes, then every 15 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
31/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients will be randomly allocated to one of the two groups
using a computer-generated random number table. Concealment will be done using
consecutively numbered sealed opaque envelopes.
Group-LS: 12.5 mg of 0.5%
isobaric levobupivacaine (2.5 ml) + normal saline(1ml)
Group-LD: 12.5 mg of 0.5%
isobaric levobupivacaine (2.5 ml) + 4 mg dexamethasone (1 ml)
The total volume of intrathecal drug will be 3.5 ml in
both the groups.
Under continuous monitoring, subarachnoid block will
be performed under all aseptic precautions as per the standard protocol.
Patients will be assessed for characteristics of sensory and motor block, pain score,
haemodynamic parameters and side effects.
OUTCOME
MEASURES
1. Analgesic
efficacy: Duration of effective analgesia (Time from the subarachnoid
block to the time of patient’s first complaint of pain (VAS 3).
2. Quality of sensory block.
3. Quality of motor block.
4. Side effects, if any.
Statistical Analysis:
Since it’s a pilot study there
is no hypothesis testing. Post – hoc observed power will be calculated and
if found ≥ 80% we would apply test of significance. Unpaired
T-test/ Man Whitney U tests will be used to obtain the significance. A p- value
< 0.05 will be considered significant. |