| 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. |
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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 |
|
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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. |
|
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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 |
|
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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 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 |
|
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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, |
|
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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
|
|
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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
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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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 |
|
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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 |
|
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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)
|
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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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