| CTRI Number |
CTRI/2011/10/002037 [Registered on: 07/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
29/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of epidural colloid for comparison of low doses of intrathecally administered bupivacaine |
|
Scientific Title of Study
|
Comparison of low doses of intrathecal bupivacaine under combined spinal-epidural anaesthesia with epidural volume extension for caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
Department of Anaesthesia, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
2360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
Department of Anaesthesia, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
UTTAR PRADESH
244001
India |
| Phone |
2360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Jain |
| Designation |
Assistant Professor |
| Affiliation |
Teerthankar Mahaveer Medical College |
| Address |
Department of Anaesthesia, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
E-203,Faculty block, Teerthankar Mahaveer Medical College, Delhi Road, Bagarpur, Moradabad
UTTAR PRADESH
244001
India |
| Phone |
2360170 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Gaurav Jain |
Department of Anaesthesia, Teerthankar Mahaveer medical college |
Department of Anaesthesia, Second floor, Old building, Teerthankar Mahaveer medical college, Delhi road, bagarpur, Moradabad
Moradabad
UTTAR PRADESH |
9936871711
gauravhld@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee, Teerthankar mahaveer medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Booked to deliver by caesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined spinal epidural anaesthesia |
In the right lateral decubitus position, an 18-gauge Tuohy needle was placed in the L3-4 epidural space. Using a needle-through-needle technique, the duramater was punctured with a 27-gauge Whitacre spinal needle and the prepared comparator agent was injected through it as per group allocation. The spinal needle was then withdrawn and Dextran 40 w/v 10 ml injected via an epidural needle. An epidural catheter was then inserted 4 cm into the epidural space and secured in place. |
| Comparator Agent |
Group I |
4 mg (0.8 ml)hyperbaric bupivacaine with 25 micro gram (0.5 ml) fentanyl. The solution was then diluted to 2.5 ml volume with normal saline. |
| Comparator Agent |
Group II |
5.5 mg (1.1 ml)hyperbaric bupivacaine with 25 micro gram (0.5 ml) fentanyl. The solution was then diluted to 2.5 ml volume with normal saline |
| Comparator Agent |
Group III |
7 mg (1.4 ml)hyperbaric bupivacaine with 25 micro gram (0.5 ml) fentanyl. The solution was then diluted to 2.5 ml volume with normal saline |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA Physical Status I or II,
height 145-165 cm,
body mass index of 25+/-10%,
> 37 weeks of gestation,
single nun-complicated pregnancy |
|
| ExclusionCriteria |
| Details |
weight more than 100 kg,
pregnancy-induced hypertension,
end-organ disease,
in active labour,
emergency caesarean section
any contraindication to regional anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of effective doses |
During intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of lower limb motor block |
At 5 min intervals for the first 20 min after giving combined spinal epidural anaesthesia and at 10 min intervals thereafter. |
| Upper level of dermatomal sensory block |
At 5 min intervals for the first 20 min after giving combined spinal epidural anaesthesia and at 10 min intervals thereafter. |
| Adequecy of muscle relaxation |
By operating surgeon during intraoperative period |
| Complications |
During intraoperative period |
| APGAR score |
Of neonate at 1 and 5 min after birth |
| Need of epidural top-ups |
During intraoperative period |
| Time to modified bromage score 6 |
Post operative period |
| Time to sensory regression to T10 level |
Post operative period |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Epidural volume extension is a reliable technique that reduces the dose requirement of intrathecal bupivacaine, in combined spinal-epidural anaesthesia (CSEA).Though this technique results in a stable maternal haemodynamics, the chances of failed anaesthesia are high. This study aims to compare relative efficacy of three different low doses of intrathecal bupivacaine under CSEA with epidural volume extension for caesarean delivery. |