| CTRI Number |
CTRI/2024/12/078332 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Hyperbaric Levobupivacaine 0.5% with Hyperbaric Levobupivacaine 0.5% plus Fentanyl for Spinal anesthesia to Evaluate Sensory and Motor blockade duration in participants undergoing Infraumbilical surgery |
|
Scientific Title of Study
|
A Comparative study of Hyperbaric Levobupivacaine 0.5 percent with Hyperbaric Levobupivacaine 0.5 percent plus Fentanyl on Sensory and Motor characteristics for Spinal Anaesthesia in Infra Umbilical surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVARAJA CHANNAPPA KARAKOORA |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical College and research institute |
| Address |
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Bangalore
KARNATAKA
560002
India |
| Phone |
8880017275 |
| Fax |
|
| Email |
drsck.mbl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAHAMAD JAVEEDULLA BAIG |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical College and research institute |
| Address |
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Bangalore
KARNATAKA
560002
India |
| Phone |
9886444173 |
| Fax |
|
| Email |
Javidbeig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHAMAD JAVEEDULLA BAIG |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical College and research institute |
| Address |
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road,Fort,Bangalore
KARNATAKA India
Bangalore
KARNATAKA
560002
India |
| Phone |
9886444173 |
| Fax |
|
| Email |
Javidbeig@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Bangalore medical College and research institute |
| Address |
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
| 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 |
| Dr Mahamad Javeedulla Baig |
Bangalore medical College and research institute |
Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road,Fort, Bangalore-560002 Bangalore KARNATAKA
Bangalore
KARNATAKA |
9886444173
javidbeig@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical College and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K41||Femoral hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrathecal Hyperbaric Levobupivacaine 0.5% heavy |
Patients will receive 0.5% Hyperbaric Levobupivacaine 3ml(15mg) plus 1ml 0.9% normal saline once intrathecally over 15-20 seconds |
| Comparator Agent |
Intrathecal hyperbaric levobupivacaine 0.5% heavy with fentanyl |
Patients will receive 0.5% Hyperbaric Levobupivacaine 3ml(15mg) plus 12.5mcg Fentanyl once intrathecally over 15-20 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 18-60 years undergoing infraumbilical surgeries under subarchnoid block except LSCS
2.Patients willing to give written informed consent
3.Patients belonging to ASA I and II
4.Patient with height in the range of 150 cm to 175 cm
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of hypersensitivity to local anesthetics.
2.Subjects having any absolute contraindications for spinal anaesthesia like increased ICP, severe hypovolemia , bleeding diathesis , local site infection, neurological deficit, spinal deformity.
3. Patients with neurological or psychiatric disorders or with communication problems.
4.Patients on antihypertensive medications.
5.ASA 3/4/5
6.Pregnant women undergoing LSCS
|
|
|
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 |
| Onset of sensory block, time for maximum sensory blockade, two segment sensory regression, duration of sensory block,onset of motor blockade, maximum motor block, duration of motor block, duration of analgesia. |
Sensory blockade will be tested every 30 seconds from time of injection of drug till the
loss of sensation at T10 dermatomal level and thereafter at 2 mins intervals
till the maximum level of sensory blockade is achieved and subsequently at 30
mins interval until complete recovery. Motor block will be assessed every 1 minute for the first 5 min, then at 5-min intervals for next 30
minutes and at every 30 minutes intervals until complete resolution of motor
anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters
Blood pressure, changes in heart rate |
After injection of drug
every 1 Minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes
And at 15 minute intervals till the end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
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
|
Subarachnoid block (SAB) is a technique of regional anesthesia widely used for surgery of lower limbs, pelvic organs,lower abdomen and for cesarean sections because of its simplicity, rapid onset and reliability¹.
Hyperbaric bupivacaine 0.5%, an amide local anesthetic is presently the most common drug used for obstetric anaesthesia2 .Following the reports of cardiovascular toxic effects of bupivacaine by Albrights in 1979, relative pharmacological behaviors of both R(+) and S(−) enantiomers of bupivacaine were studied intensively and the S(−) enantiomer (levo-enantiomer) appeared to have a safer pharmacological profile 3.
Compared to plain solutions, hyperbaric solutions are expected to provide a more predictable block with fewer side effects i.e. high block, hypotension, nausea, vomiting, and pruritus4 .
Additives are drugs added to local anaesthetics that exert direct analgesic effect and prolongs duration of sensory and motor blockade, reduces the dose of local anaesthetic needed5.
As there is still lack of clinical studies on comparison of effects of these two groups in infraumbilical surgeries, the aim of this study is to compare the anesthetic effect and hemodynamic effects of hyperbaric levobupivacaine 0.5% with hyperbaric levobupivacaine 0.5% plus fentanyl in infrumbilical surgery.
|