| CTRI Number |
CTRI/2023/02/049556 [Registered on: 08/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Spinal Anaesthesia for lower abdominal and lower limb surgeries- Comparison of Heavy formulations of Levobupivacaine, ropivacaine with racemic bupivacaine |
|
Scientific Title of Study
|
Subarachnoid block for elective infraumbilical surgeries- Comparison of hyperbaric solutions of Levobupivacaine and Ropivacaine with Hyperbaric racemic bupivacaine- A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juliet Ann Abraham |
| Designation |
PG Resident |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
Department of Anaesthesiology,
MOSC Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9188605017 |
| Fax |
|
| Email |
juliet_ann19@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sam Philip |
| Designation |
Professor |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
Department of Anaesthesiology,
MOSC Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sam Philip |
| Designation |
Professor |
| Affiliation |
MOSC Medical College Hospital, Kolenchery |
| Address |
Department of Anaesthesiology.
MOSC Medical College Hospital,
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College Hospital, Kolenchery, Ernakulam, Kerala- 682311, India |
|
|
Primary Sponsor
|
| Name |
Dr Juliet Ann Abraham |
| Address |
Department of Anaesthesiology,
MOSC Medical College Hospital,
Kolenchery, Ernakulam, Kerala- 682311
|
| Type of Sponsor |
Other [self] |
|
|
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 Juliet Ann Abraham |
MOSC Medical College Hospital |
Department of Anaesthesiology,
Ernakulam
KERALA |
9188605017
juliet_ann19@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Malankara Orthodox Syrian Church Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (3) ICD-10 Condition: M22||Disorder of patella, (4) ICD-10 Condition: M21||Other acquired deformities of limbs, (5) ICD-10 Condition: M00-M02||Infectious arthropathies, (6) ICD-10 Condition: M15-M19||Osteoarthritis, (7) ICD-10 Condition: M65-M67||Disorders of synovium and tendon, (8) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (9) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (10) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (11) ICD-10 Condition: T79-T79||Certain early complications of trauma, (12) ICD-10 Condition: N20-N23||Urolithiasis, (13) ICD-10 Condition: N25-N29||Other disorders of kidney and ureter, (14) ICD-10 Condition: N40-N53||Diseases of male genital organs, (15) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (16) ICD-10 Condition: K38||Other diseases of appendix, (17) ICD-10 Condition: K41||Femoral hernia, (18) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric 0.5% Levobupivacaine Hydrochloride |
Hyperbaric 0.5% Levobupivacaine hydrochloride 2.6 ml with Fentanyl citrate 20 mcg, single neuraxial blockade |
| Intervention |
Hyperbaric 0.75% Ropivacaine hydrochloride |
Hyperbaric 0.75% Ropivacaine hydrochloride 2.6ml with Fentanyl citrate 20 mcg, single neuraxial blockade |
| Comparator Agent |
Hyperbaric Racemic 0.5% Bupivacaine Hydrochloride |
Hyperbaric 0.5% racemic Bupivacaine hydrochloride 2.6 ml with Fentanyl citrate 20 mcg, single neuraxial blockade |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-11
Age 20- 70 years
Height 150-180cms
Infraumbilical surgeries >2 hours
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Local infection
Coagulopathies
Allergy to the study drugs
Any pre-existing neurological deficits
Parturients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of onset and duration of motor blockade |
The onset of the maximum motor blockade- attaining Grade 4 on the Modified Bromage scale- checked every 3 mins from the time of administration (3 mins, 6 mins, 9 mins, 12 mins)
The duration of the motor blockade- from the onset of the motor blockade [(Grade 4 on Modified Bromage scale), peaking at (Modified Bromage scale Grade 1)]till the effect of the drug is completely subsided (Modified Bromage scale Grade 6) - checked every 20 mins post-surgery (20 mins, 40 mins, 60 mins..120mins ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the onset and duration of sensory blockade |
The onset of the sensory blockade - blockade at the level of T10 dermatome - checked every minute from the time of administration of the drug (1 min, 2 min, 3 min, 4 min, 5 min)
The duration of the sensory blockade -from the onset of sensory blockade (sensory blockade at T10 dermatomal level) till the requirement of first rescue analgesia (checked every 15 minutes post-op till the 1st hour)- and then every hour till the first 6 hours- 2nd hr, 3rd hr... 6th hour) |
| To compare the total consumption of rescue analgesia when the comparator agent and interventional agents are administered |
The total consumption of rescue analgesia is determined by the need for intravenous analgesics for the first 6 hours post-surgery (1st hour, 2nd hr...6th hour) |
| Comparison of intraoperative hemodynamic profile and occurrence of adverse effects with each study drug |
Vitals are recorded every two minutes from the time of administration of the drug (0 min, 2 mins, 4 mins...) for the first 20 minutes and then every 5 minutes till the end of the surgical procedure.
The adverse effects of each drug are duly noted. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal Anaesthesia is the gold standard for infraumbilical surgeries. Commonly used as spinal anaesthetic is 0.5% Hyperbaric Bupivacaine in spite of their cardiotoxic and neurotoxic property, if intravascular access is gained. This is due to the R- enantiomer component which has increased affinity for the sodium channels in cardiac tissue. This led to the formulation of levobupivacaine and ropivacaine, pure S-enantiomers and long acting local anaesthetic agents. Until recently Hyperbaric solutions of levobupivacaine and ropivacaine were not available. Hence this study. It is a proposed randomised control trial, where the patients are counselled regarding the procedure and their consent is attained. They are divided into groups of three with 35 in each given and given their allocated drug. The different parameters studied are the onset and duration of motor and sensory blockade, post-operative analgesia, hemodynamic parameters and complications. The results are then tallied to compare the efficiency and safety profile of levobupivacaine and ropivacaine against racemic bupivacaine. |