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CTRI Number  CTRI/2024/08/072662 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 15/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   COMPARATIVE EVALUATION OF BUPIVACAINE VS LEVOBUPIVACAINE FOR DURATION OF ANALGESIA IN SUBARACHNOID BLOCK SUPPLEMENTED WITH INTRAVENOUS DEXAMETHASONE IN LOWER ABDOMINAL SURGERIES. 
Scientific Title of Study   COMPARATIVE EVALUATION OF BUPIVACAINE VS LEVOBUPIVACAINE FOR DURATION OF ANALGESIA IN SUBARACHNOID BLOCK SUPPLEMENTED WITH INTRAVENOUS DEXAMETHASONE IN LOWER ABDOMINAL SURGERIES 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jasmeet Kaur Gulati 
Designation  PG Resident 
Affiliation  School of Medical sciences and Research, Sharda Hospital  
Address  Department of Anaesthesia School of Medical Sciences and Research, Sharda Hospital, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9999860964  
Fax    
Email  jasmeetgulati14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr UTTAM CHANDRA VERMA  
Designation  Professor & HOD 
Affiliation  School of Medical sciences and Research, Sharda Hospital 
Address  Department of Anaesthesia School of Medical Sciences and Research, Sharda Hospital, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr JASMEET KAUR GULATI 
Designation  PG 
Affiliation  School of Medical sciences and Research, Sharda Hospital 
Address  Department of Anaesthesia School of Medical Sciences and Research, Sharda Hospital, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9999860964  
Fax    
Email  jasmeetgulati14@gmail.com  
 
Source of Monetary or Material Support  
School of Medical Sciences and Research, Sharda Hospital. 
 
Primary Sponsor  
Name  School of Medical Sciences and Research Sharda Hospital 
Address  Knowledge Park 3, Greater Noida Uttar Pradesh 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jasmeet Kaur Gulati  SMS&R, SHARDA UNIVERSITY  Department of Anaesthesia School of Medical Sciences and Research, Sharda Hospital, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India
Gautam Buddha Nagar
UTTAR PRADESH 
09999860964

jasmeetgulati14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, School of Medical Sciences and Research, Sharda Hospital, Greater Noida  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine  Patient will be given 0.5% hyperbaric Bupivacaine, 3 ml (15mg) along with injection fentanyl 25mcg intrathecally. Total volume of 3.5ml. Dexamethasone (0.15 mg/kg) intravenously after subarachnoid block.  
Comparator Agent  Levobupivacaine  Patient will be given 0.5% hyperbaric Levobupivacaine, 3 ml (15mg) along with injection fentanyl 25mcg intrathecally. Total volume of 3.5ml. patients will receive Dexamethasone (0.15 mg/kg) intravenously after subarachnoid block  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled for lower abdominal surgeries under subarachnoid block.
2.ASA class I and II
3.Age 18-60 years
4.Height 150-170 cm
5.BMI less than 30 kg per meter square
6.Both gender
 
 
ExclusionCriteria 
Details  1. History of allergy to local anaesthetic.
2. History of usage of corticosteroids, opioids and any other analgesics.
3. Pregnant females.
4. Coagulopathy or bleeding diathesis.
5. History of hypertension, diabetes mellitus and thyroid disease
6. History of CNS, cardiovascular and renal disease.
7. Presence of any active infection in the body
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the 0.5% Hyperbaric Bupivacaine V/S hyperbaric 0.5% Levobupivacaine for duration of analgesia in subarachnoid block supplemented with intravenous dexamethasone (0.15mg/kg).  24 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the duration required with regard to
Sensory block
Motor block

To evaluate & compare its effects on
VAS Score
Post op nausea & vomiting
Opioid (Fentanyl) consumption
Blood Glucose Levels  
24 Hours 
 
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)   31/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Adequate postoperative analgesia is central to avoid both the acute as well as chronic complications of uncontrolled postoperative pain. An optimal multimodal regimen may be determined based on identifying efficacious, safe, and inexpensive analgesic interventions. Key components of an optimal multimodal analgesic regimen include the preoperative identification of patients at high risk for postoperative pain in addition to patient and caregiver education. Unless contraindicated, all patients should receive a combination of acetaminophen, non-steroidal anti-inflammatory drug or cyclo-oxygenase-2-specific inhibitor, dexamethasone, and procedure-specific regional analgesic technique and/or surgical site local anaesthetic infiltration.[1]
Multimodal analgesia approaches have been suggested to manage postoperative pain. One of these is the injection of dexamethasone. Acute inflammation induced by tissue damage has a major role in development of postoperative pain, nausea, and vomiting. Therefore, dexamethasone should be useful in lowering pain, nausea, and vomiting, due to its potential anti- inflammatory effect.[1]
Dexamethasone is potent, selective glucocorticoid having minimal mineralocorticoid action. Systemic anti-inflammatory and immunosuppressive properties may be responsible for the prolongation of analgesia when administered intravenously. It has nerve block prolonging effect by blocking transmission of nociceptive myelinated c-fibres and suppressing ectopic neuronal discharge and plasma half-life of >36 hours. [2]
It has been found that many drugs, such as opioids (morphine, fentanyl, and sufentanil), α2 adrenergic agonists (dexmedetomidine and clonidine), magnesium sulphate, neostigmine, ketamine, and midazolam, can be used as adjuvants for intrathecal local anaesthetics to improve the quality of spinal anaesthesia. During the intrathecal administration, fentanyl has a more rapid onset and shorter duration of action than morphine, which has become one of the most used neuraxial opioids.[3]
 
Bupivacaine at a concentration of 0.5%, became popular and a drug of choice giving spinal anaesthesia because of its long-term block, sensory block separated from the motor block. Bupivacaine also promotes opioid binding to kappa-opioid receptors, which reduces pruritus. In recent years Levobupivacaine, effective long-acting amide, the pure S (¬) enantiomer of bupivacaine, emerged as a safer alternative for regional anaesthesia than its racemic parent. It demonstrated less affinity and strength of depressant effects on to myocardial and central nervous vital centres in pharmacodynamics studies, and a superior pharmacokinetic profile.[4]
Prevention of postoperative pain and post discharge nausea and vomiting requires a multimodal management approach using both pharmacologic and nonpharmacologic interventions. The short half-life of ondansetron (approximately 3h) effectively covers the typical ambulatory post anaesthesia care unit stay.[5]
Nonetheless, there is considerable worry about the potential side effects of dexamethasone treatment in the peri-operative context due to the well-known negative effects of corticosteroid use. As an illustration, corticosteroids are known to raise blood glucose levels through promoting insulin resistance and hepatic gluconeogenesis and this could be linked to poor results in people who are critically unwell or recovering from surgery.  Studies have shown that patients given dexamethasone prior to surgery experience postoperative hyperglycaemia.[6]


Lacunae in existing knowledge

However, after extensive literature search, it has been found that previous studies have been done for evaluating the sensory duration of subarachnoid block with hyperbaric bupivacaine supplemented with intravenous dexamethasone.But Uncertainty remains on the potential increase in the duration of sensory block after spinal anaesthesia. Nonetheless, there is no study that showed the duration of analgesia with hyperbaric bupivacaine or levobupivacaine in spinal anaesthesia supplemented with intravenous dexamethasone in lower abdominal surgeries.


 
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