| CTRI Number |
CTRI/2016/12/007606 [Registered on: 22/12/2016] Trial Registered Prospectively |
| Last Modified On: |
03/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two different doses of bupivacaine in epidural volume extension |
|
Scientific Title of Study
|
Comparison of intrathecal doses of plain bupivacaine for epidural volume extension induced sensory block augmentation: a randomised controlled double-blinded trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur
Hospital, Shahadra
East
DELHI
110095
India |
| Phone |
9868399713 |
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukundan Ramanujam |
| Designation |
Post Graduate Resident |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur
Hospital, Shahadra, Delhi
East
DELHI
110095
India |
| Phone |
9789306906 |
| Fax |
|
| Email |
iammukundan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukundan Ramanujam |
| Designation |
Post Graduate Resident |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
Department of Anesthesiology and Critical Care,
University College of Medical Sciences and Guru Teg Bahadur
Hospital, Shahadra, Delhi
East
DELHI
110095
India |
| Phone |
9789306906 |
| Fax |
|
| Email |
iammukundan@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur
Hospital |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
| Address |
University College of Medical Sciences and Guru Teg Bahadur
Hospital, Shahadra, Delhi 95 |
| 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 Asha Tyagi |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
Department of Anesthesiology and Critical Care,
Shahadra, Delhi 95
East
DELHI |
9868333713
drashatyagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-Human Research of University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
male patients undergoing Orthopedic lower limb surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PE5 (plain bupivacaine 5mg with epidural volume extension) |
5mg of plain bupivacaine will be given intrathecaly and epidural volume extension will be performed by injecting 10ml normal saline in epidural space |
| Intervention |
PE8 (plain bupivacaine 8mg with epidural volume extension) |
8mg of plain bupivacaine will be given intrathecaly and epidural volume extension will be performed by injecting 10ml normal saline in epidural space |
| Comparator Agent |
PNE5 (plain bupivacaine 5mg without epidural volume extension) |
5mg of plain bupivacaine will be given intrathecaly and no epidural instillation will be made |
| Comparator Agent |
PNE8 (plain bupivacaine 8mg without epidural volume extension) |
8mg of plain bupivacaine will be given intrathecaly and no epidural instillation will be made |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
ASA status I or II with
body weight between 50-70 kg and
height of 150-180 cm
undergoing lower limb surgery using combined spinal epidural technique. |
|
| ExclusionCriteria |
| Details |
Patients with diabetes mellitus, history of spinal disease or coagulation abnormalities, skin infection at site of injection and other contraindications to combined spinal epidural anesthesia including hypersensitivity to local anesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The maximum sensory block level (Smax) achieved |
The sensory blockade will be assessed every 3 min till there is no further increase in 3 consecutive readings. This level of sensory blockade will be designated as maximum level of sensory block (Smax). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The increase in maximum sensory block level caused by epidural volume extension |
The sensory blockade will be assessed every 3 min till there is no further increase in 3 consecutive readings. This level of sensory blockade will be designated as maximum level of sensory block (Smax). |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2017 |
| Date of Study Completion (India) |
05/02/2018 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is a comparison of two diffrent doses of plain bupivacaine (5m and 8mg) for epidural volume extension induced sensory block augumentation. It aiims to evaluate whether the intrathecal dose affects the efficacy of epidural volume extension. We will determine and compare, in patients undergoing orthopaedic surgery for lower limb,the maximum sensory block level achieved with or without epidural volume extension, following intrathecal injection of 5 mg Plain bupivacaine (along with 25μg fentanyl). The same will be done for 8mg of intrathecal plain bupivacaine. Combined spinal epidural anesthesia will be performed according to standrad practice. Epidural volume extension will be performed by injecting 10ml normal saline in epidural space The comparison of Smax with or without epidural volume extension following either intrathecal dose i.e., between groups PE5 and PNE5; and between PE8 and PNE8; as well as that of ∆Smax with either dose of intrathecal bupivacaine; will be done using Mann Whitney-U test. For other comparisons, appropriate statistical tests will be applied as required. A p-value <0.05 will be considered statistically significant. Sample size was determined using two-sided, two-sample t-test for comparing means at a power of 80% and α error of 5%. Taking previously reported standard deviation of 1 dermatome in the maximum sensory block level after 5 mg and 8 mg intrathecal plain bupivacaine in patients undergoing lower limb surgery, 17 patient would be required in each group to detect a difference of 1 dermatome following epidural volume extension. Adding another 10% for possible withdrawals due to various reasons such as failure of block, and 15% for the maximum sensory level being non-parametric in distribution, at least 21 patients would be required in each group. |