| CTRI Number |
CTRI/2020/12/030163 [Registered on: 31/12/2020] Trial Registered Retrospectively |
| Last Modified On: |
18/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy of two local anaesthetic agents (levobupivacaine and ropivacaine) with routinely used bupivacaine local anaesthetic for cesarean delivery by spinal anaesthesia. |
|
Scientific Title of Study
|
SPINAL ANESTHESIA FOR ELECTIVE CAESAREAN SECTION- COMPARISION OF LEVOBUPIVACAINE AND ROPIVACAINE WITH HYPERBARIC RACEMIC BUPIVACAINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Melwin George |
| Designation |
Consultant |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Department of Critical Care Medicine
3rs floor Medical Intensive Care Unit
RAJAGIRI HOSPITAL
Thrissur
KERALA
683112
India |
| Phone |
9995238342 |
| Fax |
|
| Email |
drmelwing@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaloo Ipe |
| Designation |
HOD and Professor |
| Affiliation |
MOSC medical college |
| Address |
Department of anesthesiology
Malankara Orthodox Syrian Church Medical College
kolenchery
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9495126722 |
| Fax |
|
| Email |
shaloo_ipe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaloo Ipe |
| Designation |
HOD and professor |
| Affiliation |
MOSC medical college |
| Address |
Department of Anesthesiology
Malankara Orthodox Syrian Church Medical College
kolenchery
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9495126722 |
| Fax |
|
| Email |
shaloo_ipe@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Aesmira Life Sciences |
| Malankara Orthodox Syrian Church Medical College Hospital Pharmacy |
| Neon LABORATORIES LTD |
|
|
Primary Sponsor
|
| Name |
Malankara Orthodox Syrian Church Medical College |
| Address |
Medical College Road
Kolenchery PO
Ernakulam
682311 |
| Type of Sponsor |
Private 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 Melwin George |
Malankara Orthodox Syrian Church Medical College |
Department of Anesthesiology
MOSC Medical college
Ernakulam
KERALA |
9995238342
drmelwing@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Heavy Bupivacaine |
Dose: 0.5% Heavy Bupivacaine 1.8ml + Fentanyl 25mcg(.5ml)
Frequency/duration: single shot
Route: intrathecal |
| Intervention |
Levobupivacaine |
Dose: 0.5% Levobupivacaine 1.8ml + Fentanyl 25mcg(.5ml)
Frequency/duration: single shot
Route: intrathecal |
| Intervention |
Ropivacaine |
Dose: 0.5% Ropivacaine 1.8ml + Fentanyl 25mcg(.5ml)
Frequency/duration: single shot
Route: intrathecal |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA 1 Parturient
2. Height 145-175cms
3. Singleton term pregnancy
4. Elective caesarean section |
|
| ExclusionCriteria |
| Details |
1. Parturient refusal
2. Local infection
3. Coagulopathy
4. Allergy to the study drugs
5. Any neurological deficit
6. Multifoetal gestation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anesthetic efficacy of study drugs
comaprison of sensory, motor charactersitics of the study drug
complications
neonatal outcome |
1. Sensory assessment: every 2 min from 2 to 20 min and then every 10min until recovery to T12
2. Motor assessment: at baseline, then 2, 4, 6, 10, 15, and 20 mins after intrathecal injection and as soon as possible at the end of surgery. Every 10min after surgery.
3. Hemodynamics: at 2-minute intervals for 20 mins and 10 mins interval throughout the surgery and one-hour interval up to six hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SEVERITY OF COMPLICATION |
DURING FIRST 20MINUTES AFTER THE SPINAL ANESTHESIA |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/12/2012 |
| Date of Study Completion (India) |
09/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abstract Background: Spinal anaesthesia is a popular technique for caesarean section. Our study was designed
to determine the efficacy and safety of newer local anaesthetics, Levobupivacaine and Ropivacaine and
compare it with commonly used Hyperbaric Bupivacaine for spinal anaesthesia in elective caesarean
section.
Method: In this prospective, randomized controlled, double-blind study, 90 parturients were allocated
to three groups of 30 each. Group A (control) received 0.5% Hyperbaric Bupivacaine 1.8ml with 25mcg
Fentanyl, Group B (study) received 0.5% Levobupivacaine 1.8ml with 25mcg with Fentanyl, Group C
(study) received 0.75% Ropivacaine 1.8ml with 25mcg Fentanyl. The study drug was considered
effective if an upper sensory level of T6 or above was achieved and if intraoperative supplementation
was not required for successful completion of surgery. Parturients hemodynamic parameters, sensory,
motor characteristics and complications as well as neonatal safety were assessed.
Results: Anaesthesia was effective in 96.7% of parturients in A and C groups and 80% in B group.
Duration of motor block was shorter in B (112.83±21.57mins P=.000) and C (122.06±19.84mins P=.016)
groups compared to A group (136.96±18.87mins). Mean duration of analgesia was lesser in B
(208.33±44.54mins, P=.001) and C (218.62±21.91mins, P=.010) groups when compared to A
(245.96±35.99mins). Episodes of intraoperative hypotension and the amount of Ephedrine consumed
were higher in C group compared to group A (P=0.039). Maternal and neonatal outcomes were
satisfactory in all the three groups.
Conclusion: Ropivacaine 0.75% was as efficacious as Hyperbaric Bupivacaine 0.5% in providing
satisfactory spinal anaesthesia for caesarean section. Levobupivacaine 0.5% was found to be inferior to
Bupivacaine and Ropivacaine in terms of efficacy. Duration of analgesia and duration of motor blockade
was shorter with Levobupivacaine and Ropivacaine when compared to Bupivacaine. Maternal and
neonatal safety were ensured in all the three groups.
Keywords: Bupivacaine; Levobupivacaine; Ropivacaine; Fentanyl; spinal anaesthesia; caesarean section. |