| CTRI Number |
CTRI/2017/10/010209 [Registered on: 26/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Clinical Effect of Levobupivacaine (local anaesthesia) and bupivacaine (local anaesthesia)in Spinal Anaesthesia for cesarean section.
|
|
Scientific Title of Study
|
Comparison of isobaric levobupivacaine versus hyperbaric bupivacaine in spinal anesthesia for cesarean section: A prospective unmatched case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Udita Naithani |
| Designation |
Professor |
| Affiliation |
Rabindranath Tagore medical college |
| Address |
Department of Anaesthesiology,
R.N.T medical college
Court circle,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
drvinaynaithani@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Udita Naithani |
| Designation |
Professor |
| Affiliation |
Rabindranath Tagore medical college |
| Address |
Department of Anaesthesiology,
R.N.T medical college
Court circle,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
drvinaynaithani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Madhanmohan C |
| Designation |
PG student |
| Affiliation |
Rabindranath Tagore medical college |
| Address |
Department of Anaesthesiology,
R.N.T medical college
Court circle,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9166774973 |
| Fax |
|
| Email |
madhanmohan89@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| R.N.T medical college and associated hospitals, Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Pannadhai Zanana Hospital attached to RNT medical college |
| Address |
R.N.T medical college,
Court circle,
Udaipur - 313001
Rajasthan, India |
| 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 |
| Udita Naithani |
Panadhai Zanana Hospital |
Dept of Anesthesiology, I floor, room no 1 of ZOT,
R.N.T medical college
Court circle
Udaipur
RAJASTHAN |
9829414752
drvinaynaithani@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.N.T medical college & Controller & attached hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy (no associated medical illness) parturients advised to undergo cesarean section under spinal anesthesia., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
levobupivacaine 0.5% 2.5 ml (12.5mg) |
isobaric levobupivacaine without any additive administered intrathecally via spinal needle as spinal anaesthesia for undergoing cesarean section |
| Comparator Agent |
hyperbaric bupivacaine 0.5% 2ml(10mg) without any additive |
hyperbaric bupivacaine without any additive administered intrathecally via spinal needle as spinal anaesthesia for undergoing cesarean section |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA I,II Healthy parturients advised to undergo elective and semi elective cesarean sections for indications
2.previous CS
3.Breech,
4.Cephalopelvic disproportion
5.Pregnancy following infertility treatment, 6.Postdatism,
7.Cord around neck
8.Non-progress of labour |
|
| ExclusionCriteria |
| Details |
1.Allergy to amide Local anesthetic
2.Any associated systemic illness having cardiovascular, neurological, renal, pulmonary, autoimmune, psychiatric, end stage liver disease etc.)
3.Any coagulation abnormality.
4.Morbid obesity
5.Short stature.
6.Having fetal anomaly
7.Any contraindication to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate ( number of cases in whom surgery could be completed without supplementation )
|
Outcome of the study will be observed after the end of surgery and patients recover to preoperative condition. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
(1) Sensory block characteristics ( time to onset , peak sensory level , and duration)
(2) Motor block characteristics (time to onset, maximum motor block , and duration)
(3) Duration of analgesia
(4) Haemodynamic profile
(5) Complications
(6) Patient & surgeon satisfaction
|
every min till 10 min, at the end of surgery and every 30 min thereafter till complete recovery achieved |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2016 |
| Date of Study Completion (India) |
14/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
Both
groups were comparable regarding age, ASA grade, duration of surgery and
preoperative vital parameters
Sensory Motor Block characteristics:
Sensory onset was significantly faster with hyperbaric bupivacaine as compared
to isobaric levobupivacaine, as shown by difference in time to T8 (3.12±0.86
min in group L, 2.8 ±0.74 min in group B, p = 0.048) and time to T6
(4.28±1.04 min in group L, 3.8±0.81 min in group B, p = 0.011) though this
difference of less than 1 min was clinically not significant. All patients of both groups achieved target
sensory level of T6 which was necessary to start caesarean section
in spinal anaesthesia. Peak sensory level at 10 min ranged from T3-T6
in both groups however median value was
T6 in group L as compared to T4 in group B. Mean value of
peak sensory level was comparable in two groups (T4.74±1.03 in group
B and T5.12±0.97in group L, p =0.060). The time to reach peak
sensory level was also statistically comparable in two groups (4.68±0.81 min in
group L, 4.44±0.63 min in group B, p = 0.095).
All
patients of both groups achieved maximum Bromage score of 3, signifying
complete motor block. Motor onset in terms of time to achieve maximum Bromage
of 3 was significantly faster with hyperbaric bupivacaine (3.04±0.69 min in
group B) as compared to isobaric levobupivacaine (3.56±0.63 min in group L),
p=0.0002, however this difference of less than 1 min was clinically not
significant.
Duration
of analgesia (time to first rescue analgesia)
was significantly longer in group B (155.7±14.35 min) as compared to group L
(140.3±12.74 min), p=0.0001. Sensory block duration was significantly
longer in group B (210.7±22.18 min) as compared to group L (186.0±21.26 min), p
= 0.0001. Motor block duration was significantly longer in group B
(250.9±24.20 min) as compared to group L (223.9±23.11 min), p = 0.0001
Haemodynamic Parameters:
There was no significant difference in mean value of systolic BP, diastolic BP,
pulse rate and SpO2 in both groups throughout the study period
(p>0.05).
Adverse effects: Occurrence of hypotension was comparatively more in group B, [36% (n=18)] as
compared to group L [28% (n=14)], p > 0.05. Perioperative nausea and
vomiting was also more in group B (8%, n =4) than in group L (4%, n =2), p >
0.05. No neonatal and maternal complications or any other adverse effects were
observed.
Success rate (clinical efficacy) of spinal block:
Incidence of “completely successful†spinal block (no supplementation) was 100%
(n=50) in both the groups. None of the patient in both groups required
anaesthetic supplementation or general anaesthesia. Both 12.5 mg isobaric levobupivacaine and 10 mg hyperbaric
bupivacaine in spinal anaesthesia were graded as “perfect agent†for CS, owing
to 100% complete success rate in both groups. |