| CTRI Number |
CTRI/2023/09/058070 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of two drugs, ropivacaine and levobupivacaine in patients undergoing cesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
A comparitive evaluation of hemodynamic effects between
hyperbaric Ropivacaine and hyperbaric Levobupivacaine in elective LSCS
under spinal anaesthesia; a one year randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niyaz Abdul Salam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College
campus, Nehru Nagar, Belagavi
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9972673892 |
| Fax |
|
| Email |
niyazsalam7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kedareshvara K S |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital
and Medical Research Centre, Jawaharlal Nehru Medical College
campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886375154 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niyaz Abdul Salam |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
9972673892 |
| Fax |
|
| Email |
niyazsalam7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical
College - Belagavi |
|
|
Primary Sponsor
|
| Name |
Niyaz Abdul Salam |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital
and Medical Research Centre, Jawaharlal Nehru Medical College
campus, Nehru Nagar, Belagavi, Karnataka |
| 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 |
| Niyaz Abdul Salam |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of
Anaesthesiology, KLES
Prabhakar Kore
Hospital and Medical
Research Centre,
Jawaharlal Nehru
Medical College
campus, Nehru Nagar
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9972673892
niyazsalam7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal anaesthesia with hyperbaric levobupivacaine |
Spinal anesthesia has been a popular method of anaesthesia for short, lower abdominal surgeries. Hyperbaric racemic bupivacaine is commonly used for spinal anaesthesia due to its long duration of action and combined motor and sensory blockade. However there are other preparations which can be used for the same with its own advantages and disadvantages.
Intrathecal use of hyperbaric LA agents has become more popular as they produce predictable block characteristics and reliable SA. Another formulation of a local anesthetic, i.e., hyperbaric levobupivacaine is being made more available in India. It is known that levobupivacaine has a lower propensity to cause hypotension and bradycardia and causes early motor recovery.
A thorough pre-anesthetic evaluation will be done on the day before surgery. On the day of surgery, intravenous access will be secured using 18G or 20 G iv cannula and iv fluids is started. The patient will be prealoaded on 8ml/kg fluids over 20 minutes. Standard monitoring devices are attached before induction of anaesthesia, including non-invasive arterial blood pressure, heart rate, ECG and oxygen saturation. A pre procedure measure of the NIBP and the heart rate will be recorded and under sterile aseptic precautions, a 25G spinal needle will be introduced into the SAS of the patient at relevant level. Spinal anesthesia will be performed in the sitting position by using a midline approach at the L3-4 interspace. Once free flow of clear cerebrospinal fluid was obtained, 2.2ml of the study drug will be injected at the rate of approximately 0.2 mL/s. With the spinal needle bevel facing cephalad, the anesthetic solution will be injected without barbotage or aspiration.
|
| Intervention |
Spinal anaesthesia with hyperbaric ropivacaine |
Spinal anesthesia has been a popular method of anaesthesia for short, lower abdominal surgeries. Hyperbaric racemic bupivacaine is commonly used for spinal anaesthesia due to its long duration of action and combined motor and sensory blockade. However there are other preparations which can be used for the same with its own advantages and disadvantages.
Intrathecal use of hyperbaric LA agents has become more popular as they produce predictable block characteristics and reliable SA. Ropivacaine, a newer amino-amide local anesthetic (LA) agent similar to bupivacaine in chemical structure, but 30-40% less potent than bupivacaine has been well-studied for spinal anesthesia (SA). The preliminary studies evaluated the efficacy and safety of isobaric ropivacaine for neuraxial blockade.
Intrathecal ropivacaine was found to be safe, having shorter duration of action than bupivacaine and lesser incidence of transient neurological symptoms (TNS) as compared with intrathecal lignocaine.
A thorough pre-anesthetic evaluation will be done on the day before surgery. On the day of surgery, intravenous access will be secured using 18G or 20 G iv cannula and iv fluids is started. The patient will be prealoaded on 8ml/kg fluids over 20 minutes. Standard monitoring devices are attached before induction of anaesthesia, including non-invasive arterial blood pressure, heart rate, ECG and oxygen saturation. A pre procedure measure of the NIBP and the heart rate will be recorded and under sterile aseptic precautions, a 25G spinal needle will be introduced into the SAS of the patient at relevant level. Spinal anesthesia will be performed in the sitting position by using a midline approach at the L3-4 interspace. Once free flow of clear cerebrospinal fluid was obtained, 2.2 ml of the study drug will be injected at the rate of approximately 0.2 mL/s. With the spinal needle bevel facing cephalad, the anesthetic solution will be injected without barbotage or aspiration.
After the injection of the spinal medication, the patients will be turned supine with left uterine displacement. Maternal heart rate and arterial blood pressure will be measured with an automatic, noninvasive device. Baseline values will be defined as blood pressure and heart rate values before the preanesthetic infusion.
The patients blood pressure, mean arterial pressure and heart rate will be measured before induction after which it will be measured every 2,4,6,8,10,15,30,45,60,90 minutes.The assessments of sensory block to pinprick will be performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection and then every 15 min until regression to L5. Results of the pinprick test will be determined bilaterally at midclavicular level by using a short beveled spinal gauge needle. Motor block in the lower limb will be assessed by using a modified Bromage scale. These assessments will be performed immediately after the assessments of sensory block until the return of normal motor function.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status I and II.
Age between 20 to 40 years.
Weight ranging from 70-90kg
Height ranging from 155-185cm (5ft to 6ft)
Patients undergoing elective LSCS under spinal anesthesia
Provides Consent
|
|
| ExclusionCriteria |
| Details |
Patient undergoing emergency surgery.
Patient who are unable to give consent.
Patient with obstetric complications
Patient with suspected fetal compromise
Coagulopathy
Patients who do not fulfill inclusion criteria.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hyperbaric ropivacaine to hyperbaric levobupivacaine with respect to hemodynamic responses’; blood pressure, heart rate and mean arterial pressure in elective LSCS cases. |
2,4,6,8,10,15,30,45,60,90 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of spinal anaesthesia with respect to onset, duration and level of block with hyperbaric ropivacaine and hyperbaric Levobupivacaine in elective LSCS cases. |
The assessments of sensory block to pinprick will be performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection.
Motor block in the lower limb will be assessed by using a modified Bromage scale (0: no paralysis, 1: unable to raise extended leg, 2: unable to flex knee, 3: unable to flex ankle). These assessments will be performed immediately after the assessments of sensory block until the return of normal motor function. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anesthesia has been a popular method of anaesthesia for short, lower abdominal surgeries. Hyperbaric racemic bupivacaine is commonly used for spinal anaesthesia due to its long duration of action and combined motor and sensory blockade. However there are other preparations which can be used for the same with its own advantages and disadvantages. The impetus for the development of the newer stereoselective, single enantiomer amide local anaesthetic agents, ropivacaine and levobupivacaine, came from reports of fatal cardiac toxicity in pregnant women receiving epidural bupivacaine and etidocaine for Caesarean section. Although these concerns are not clinically relevant to spinal anaesthesia because of the smaller doses required, there has, nevertheless, been interest in the potential of these agents for intrathecal use. Intrathecal use of hyperbaric LA agents has become more popular as they produce predictable block characteristics and reliable SA. Ropivacaine, a newer amino-amide local anesthetic (LA) agent similar to bupivacaine in chemical structure, but 30-40% less potent than bupivacaine has been well-studied for spinal anesthesia (SA). The preliminary studies evaluated the efficacy and safety of isobaric ropivacaine for neuraxial blockade. Intrathecal ropivacaine was found to be safe, having shorter duration of action than bupivacaine and lesser incidence of transient neurological symptoms (TNS) as compared with intrathecal lignocaine. Another formulation of a local anesthetic, i.e., hyperbaric levobupivacaine is being made more available in India. It is known that levobupivacaine has a lower propensity to cause hypotension and bradycardia and causes early motor recovery. This study aims to compare the effects of hyperbaric ropivacaine and hyperbaric levobupivacaine on its use in pregnant women during elective LSCS. The new introduction of hyperbaric levobupivacaine in India and the lacunae in literature with respect to its comparison with hyperbaric ropivacaine, in terms of hemodynamic parameters, justifies the need for this study
|