| CTRI Number |
CTRI/2015/05/005814 [Registered on: 26/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2015 |
| 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
|
ROLE OF MAGNESIUM IN USG GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK |
|
Scientific Title of Study
|
A COMPARISON BETWEEN BUPIVACAINE AND BUPIVACAINE WITH MAGNESIUM SULPHATE IN TWO DIFFERENT DOSES IN TRANSVERSUS ABDOMINIS PLANE BLOCK IN PATIENTS UNDERGOING TOTAL ABDOMINAL HYSTERECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Chauhan |
| Designation |
Post graduate student, Anaesthesiology |
| Affiliation |
DR RPGMC Tanda at Kangra |
| Address |
Junior Resident, Department of anaesthesia, Dr Rajendra Prasad Government Medical College Tanda at Kangra( Himachal Pradesh)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418270079 |
| Fax |
01892-267115 |
| Email |
ankitachandelchauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shelly Rana |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia,DR RPGMC Tanda at Kangra |
| Address |
Associate Professor, Department of anaesthesia, Dr Rajendra Prasad Medical College. Tanda at Kangra( Himachal Pradesh)
Associate Professor, Department of anaesthesia, Dr Rajendra Prasad Medical College. Tanda at Kangra( Himachal Pradesh)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
01892-267115 |
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shelly Rana |
| Designation |
Associate Professor, Anaesthesiology |
| Affiliation |
Department of Anaesthesia,DR RPGMC Tanda at Kangra |
| Address |
Associate Professor, Department of anaesthesia, Dr Rajendra Prasad Government Medical College, Tanda at Kangra( Himachal Pradesh)
Associate Professor, Department of anaesthesia, Dr Rajendra Prasad Government Medical College, Tanda at Kangra( Himachal Pradesh)
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
01892-267115 |
| Email |
shelkbj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, Dr Rajendra Prasad Government Medical College Tanda at Kanga, Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government medical college and hospital Tanda |
| Address |
Dr Rajendra Prasad Government medical college and hospital Tanda, at Kangra (HP) |
| 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 |
| Ankita Chandel |
OT complex, 3rd floor, Department of anaesthesia, Dr Rajendra Prasad Medical College , Tanda, Kangra |
Operation theatre number 6, and 7, Gynaecology OT, 3rd Floor, Dr RPGMC Tanda.
Kangra
HIMACHAL PRADESH |
9418270079
01892-267115
ankitachandelchauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing total abdominal hysterectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magnesium in two different doses |
magnesium sulphate is added to bupivacaine(control)20 ml of 0.25% each side in two different doses that is 100 mg and 150 mg and three groups are made |
| Intervention |
USG guided transversus abdominis plane block |
USG guided transversus abdominis plane block given after total abdominal hysterectomy for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Females between 35 to 70 years undergoing TAH
ASA class I-II
BMI 18.5-29.9
|
|
| ExclusionCriteria |
| Details |
patient refusal, bleeding disorders, patient on calcium channel blockers,local site infection |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first analgesic requirement after TAP block |
Time to first analgesic requirement after TAP block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| supplemental analgesic requirements,Visual analog score, nausea vomiting score, patients satisfaction score |
AT 2, 4, 6, 12,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2012 |
| 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="1"
Months="11"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Efficacy of transversus abdominis plane(TAP) block for post operative analgesia has already been established. We intend to use magnesium as an adjunct to bupivacaine in TAP block after total abdominal hysterectomy and find out its effect on duration of analgesia and visual analog scores post operatively. Till now magnesium has been found to reduce analgesic requirement in postoperative period via different routes that is neuraxial, intravenous,nerve blocks, but there have been no studies comparing its effect in TAP block.
|