| CTRI Number |
CTRI/2021/08/036003 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs in anesthesia in abdominal and lower limb surgeries |
|
Scientific Title of Study
|
Comparison of 0.5% levobupivacaine alone and 0.5% levobupivacaine with butorphanol given intrathecally in infraumbilical surgeries; a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushree Pathak |
| Designation |
Junior Resident Anesthesia |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anesthesia, Rohilkhand medical college and hospital Bareilly , room number 2071 Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly,room number 2071 Bareilly UTTAR PRADESH 243006 India |
| Phone |
9335029261 |
| Fax |
|
| Email |
cuteeanushree@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Akash gupta |
| Designation |
Assistant professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of AnesthesiaRohilkhand Medical College and Hospital Bareilly Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly Bareilly UTTAR PRADESH 243006 India |
| Phone |
9935312219 |
| Fax |
|
| Email |
akku165@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anushree Pathak |
| Designation |
Junior Resident Anesthesia |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anesthesia , Rohilkhand Medical College and Hospital Bareilly, room number 2071 Department of Anesthesia Rohilkhand Medical College and Hospital Bareilly, room number 2071 Bareilly UTTAR PRADESH 243006 India |
| Phone |
9335029261 |
| Fax |
|
| Email |
cuteeanushree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Rohilkhand medical college and hospital,room number 2071 |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Pilibhit bypass road Bareilly |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Malti Agarwal |
Rohilkhand medical college and hospital |
Department of Anesthesia,room number 2071 Bareilly UTTAR PRADESH |
9358584555
dr_malti_agrawal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Rohilkhand Medical College and hospital Bareilly |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% Levobupivacaine 3ml once intrathecally for lower limb and lower abdominal surgeries to know the duration of sensory, motor effect and need for the first rescue analgesia will decide the duration of therapy may be 6 hours. |
Levobupivacaine is a local anesthetic agent given commonly in spinal anesthesia |
| Comparator Agent |
0.5% Levobupivacaine 3ml with 100 microgram (0.1ml) butorphanol once intrathecally for lower limb and lower abdominal surgeries to study the duration of sensory and motor effect during the procedure. Need of first rescue analgesia will decide the duration of therapy may be 6 hours. |
Butorphanol is an opioid given along with local anesthetic agent like levobupivacaine |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist (ASA) grade 1 or 2
Posted for surgeries of lower abdomen and lower limb |
|
| ExclusionCriteria |
| Details |
Refusal for procedure
Obesity (BMI>30)
Any neuropathy
Any allergy to local anesthetic
Contraindication to spinal anesthesia |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Butorphanol as an adjuvant to levobupivacaine .
Onset, duration of sensory and motor blockade, peak height, two segment regression time, time for first rescue analgesia will be assessed |
day1 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| sensory and motor onset |
day 1 |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
30/08/2021 |
| 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
|
NIL
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia was the first major regional technique introduced into the clinical practice. Spinal anaesthesia is a safe, reliable and also inexpensive technique. It has the advantage of providing surgical anaesthesia with prolonged post operative pain relief with use of various local anaestheticagents. It also blunts the intra-operative, autonomic, somatic and endocrine responses. Spinal anaesthesia has a faster onset and effective sensory and motor blockade. Spinal anaesthesiawas first performed in 1898 by August Bier. From then on it has been practiced extensively.1 Local anaesthetics interrupt neural conduction by inhibiting the influx of sodium ions through channels or ionophores within neuronal membranes. The molecular structure of all local anaesthetics consists of 3 components, a lipophilic aromatic ring, an ester or amide linkage and tertiary amine. Local anaesthetics are classified as short acting, intermediate and long acting. This is primarily due to differences in their affinity for protein. Bupivacaine most common LA used for regional anaesthesia but it has serious side effects like cardiac and neurotoxic. Levobupivacaine, the pure S (-) enantiomer of the racemic Bupivacaine is a long acting amide local anaestheticwhich produces differential neuraxial block. It was synthesized aiming at finding local bupivacaine but without its hazards as cardiac and central nervous system toxicity. Levobupivacaine exerts its pharmacological action through reversible blockade of neuronal sodium channels. It binds to the intracellular portion of sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. The pka of levobupivacaine is 8.1, similar to the pka of the racemic bupivacaine.2 |