| CTRI Number |
CTRI/2015/05/005749 [Registered on: 05/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of effect of addition of magnesium sulphate to bupivacaine for spinal anaesthesia in pregnant women |
|
Scientific Title of Study
|
A Randomised Controlled Double-blind trial to evaluate the effect of addition of intrathecal magnesium sulphate to hyperbaric bupivacaine on postoperative pain after lower segment caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUSHMITA ROY |
| Designation |
senior resident |
| Affiliation |
Dr.RML Hospital, New Delhi |
| Address |
2/36 ground floor, Old Rajinder Nagar, near karol bagh metro station. Delhi
New Delhi
DELHI
110060
India |
| Phone |
7838553257 |
| Fax |
|
| Email |
mita.sush17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAruna Jain |
| Designation |
Head of Department, Anaesthesia |
| Affiliation |
Lady Hardinge Medical College, New Delhi |
| Address |
Department of Anaesthesiology, Lady Hardinge Medical College, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
8588837010 |
| Fax |
|
| Email |
lhmcanaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUSHMITA ROY |
| Designation |
senior resident |
| Affiliation |
Dr.RML Hospital, New Delhi |
| Address |
2/36 ground floor, Old Rajinder Nagar, near karol bagh metro station. Delhi
New Delhi
DELHI
110060
India |
| Phone |
7838553257 |
| Fax |
|
| Email |
mita.sush17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology, Lady Hardinge Medical College, New Delhi-110001 |
| 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 |
| SUSHMITA ROY |
lady hardinge medical college, new delhi |
department of anesthesiology
lady hardinge medical college, new delhi
New Delhi
DELHI |
7838553257
mita.sush17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I/II parturients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.1 ml 50% magnesium sulphate |
2ml 0.5% hyperbaric bupivacaine + 0.1 ml of 50% magnesium sulphate (50 mg)(study) |
| Comparator Agent |
0.1 ml normal saline |
2ml 0.5% hyperbaric bupivacaine + 0.1 ml normal saline total dose was used,once at induction,by intrathecal route, and total duration of sensory and motor block and postoperative pain relief duration was noted |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA I and II parturients
Undergoing lower segment Caesarean section |
|
| ExclusionCriteria |
| Details |
patient refusal
any contraindication to regional anaesthesia
weight>90kg
height<145 or >170cm
known allergy to local anaesthetic or magnesium sulphate
dysrrthymias in ECG or any systemic disorder
history of chronic pain
already on magnesium therapy
severe psychiatric disturbance
history of drug abuse
unable to communicate in either hindi or english |
|
|
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 |
| Prolongation in duration of postoperative analgesia with addition of intrathecal magnesium sulphate to hyperbaric bupivacaine as compared to hyperbaric bupivacaine with normal saline |
time interval between administration of intrathecal block and first request for analgesia by patient(visual analog score more than 4 ) was noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory & motor block was slower while duration of sensory as well as motor block was prolonged with magnesium sulphate group. Neonatal APGAR scores and incidence of side-effects were comparable in the two groups |
Continuous ECG,HR,SpO2 were monitored. Non-invasive BP,PR & level of sedation at every 3min interval till delivery of baby,thereafter at 5min interval till end of surgey,postop at 30min interval for first 2hr then hourly till first recue analgesic
Onset of sensory block- from time of block till T6(pin-prick method)
Onset of motor block-till Bromage scale 3 reached
APGAR score-at 1 and 5 min
Duration of sensory blocktime till T12 reached
Duration of motor block-till Bromage scale 0 reached |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2011 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study was to evaluate whether addition of magnesium sulphate to intrathecal hyperbaric bupivacaine has any effect on prolonging the duration of postoperative analgesia as compared to hyperbaric bupivacaine alone, in patients undergoing lower segment Caesarean section. Also to compare the onset & duration of sensory and motor blockade, neonatal outcome and side-effects, in the two groups. We found that magnesium sulphate (50mg) as an adjuvant to hyperbaric bupivacaine intrathecally produces a significant prolongation in the duration of postoperative analgesia in patients undergoing lower segment Caesarean section.. It produces a sensory block of significantly
longer duration as compared to hyperbaric 0.5%
bupivacaine alone ; but a prolongation in the duration of motor block which
is seen with magnesium sulphate is not desirable as it delays the early
mobilisation of patients. However,
magnesium sulphate as an adjuvant to bupivacaine maybe beneficial in stable
eclamptic patients or patients in whom side-effects related to intrathecal
opioids aren’t desirable in prolonging the duration of post-operative
analgesia. The incidence of hypotension and
bradycardia were also comparable between the two groups.
|