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CTRI Number  CTRI/2024/08/073149 [Registered on: 30/08/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dose Response of Intravenous Dexamethasone on post Operative Pain With Subarachnoid Block In Lower Limb Osteoarticular Surgery. 
Scientific Title of Study   Dose response of Intravenous Dexamethasone on post operative pain with Subarachnoid block in Lower limb Osteoarticular 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  Dr SONAM 
Designation  PG 1ST YEAR RESIDENT 
Affiliation  school of medical sciences and research, Sharda Hospital 
Address  Department of Anesthesiology, school of medical sciences and research, plot no 32,34, Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8477903375  
Fax    
Email  sonamrajput881@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uttam Chandra Verma 
Designation  Professor 
Affiliation  school of medical sciences and research 
Address  Department of Anesthesiology, school of medical sciences and research, plot no 32,34, Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr SONAM 
Designation  pg 1st year resident anaesthesia 
Affiliation  school of medical sciences and research 
Address  Department of Anesthesiology, school of medical sciences and research, plot no 32,34 Knowledge Park 3, greater noida Gautam Buddha Nagar UTTAR PRADESH 201310 India

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  08477903375  
Fax    
Email  sonamrajput881@gmail.com  
 
Source of Monetary or Material Support  
school of medical sciences and research, plot no. 32,34, knowledge park 3, greater noida, uttar pradesh, 201310 
 
Primary Sponsor  
Name  school of medical sciences and research 
Address  plot no 32,34, knowledge park 3, greater Noida 
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 Sonam  sharda hospital ,school of medical sciences and research,   Department of Anesthesiology, 2nd floor,B block Gautam Buddha Nagar UTTAR PRADESH, 201310, India.
Gautam Buddha Nagar
UTTAR PRADESH 
08477903375

sonamrajput881@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Dexamethasone  Patient will receive Intravenous Dexamethasone 0.075mg/kg in 3ml. 
Comparator Agent  Intravenous Dexamethasone  Patient will receive Intravenous Dexamethasone 0.15 mg/kg in 3ml. 
Comparator Agent  Intravenous Dexamethasone  Patient will receive normal saline 3ml intravenously  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for lower limb osteoarticular surgery under subarachnoid block.
2. ASA grade I - II
3. Age 18- 60 yrs.
4. Height 150-170 cm.
5. BMI less than kg per metre square.
6. Both genders
 
 
ExclusionCriteria 
Details  1.History of allergy to local anaesthetic.
2.History of chronic use of corticosteroids, opioids and any other analgesics.
3.Pregnant females.
4.History of endocrine disease- Diabetes mellitus and thyroid disease
5.History of CNS, cardiovascular and renal disease.
6.Presence of 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 duration of analgesia with two different doses of IV Dexamethasone supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery.  24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect on with regards to:
(a)VAS score
(b)Opioid (Fentanyl) consumption
(c)Duration of sensory and motor block
(d)Postoperative nausea and vomiting
(e)Blood glucose levels.
 
24 Hoours 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   12/09/2024 
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  

Acute postoperative pain causes patient discomfort and also impedes the recovery.  Regional blocks with long-acting local anaesthetics are helpful to achieve surgical anaesthesia and longer duration of post operative analgesia. Spinal anaesthesia is widely used in lower abdominal surgeries, as it plays a crucial role in relieving postoperative pain and enabling ambulatory anaesthesia1. It is safe, cost effective and easy to perform technique, which provides a denser block and so more preferred2.

Multimodal analgesia is method of pain management in which combined medication groups include (local anaesthetics, opioids, NSAIDS, acetaminophen and alpha-2 agonists, gabapentinoids, dexamethasone) are used for pain relief.

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 and post-operative pain3.

         Dexamethasone is a potent long acting glucocorticoid with plasma half-life of 36 hrs having minimal mineralocorticoid activity, with anti-inflammatory and analgesic property. It is regarded as one of the ideal perioperative drugs being readily available, cheap, suppresses inflammation, prevent and treats postoperative nausea and vomiting, promotes appetite and provide good analgesia, when given intravenously and as an adjunct to peripheral nerve blocks. It provides good quality of recovery and early discharge of patients.

          It acts on hypothalamic pituitary adrenal axis to produce its effect. Systemic administration of dexamethasone has been found to possess anti-inflammatory and immunosuppressive properties, which may contribute to prolonged analgesia when administered intravenously4.

  Various studies suggest that intravenous dexamethasone as an adjunct with local anaesthetic prolongs the duration of spinal anaesthesia and also provides post-operative analgesia

       IV administration of dexamethasone improves postoperative VAS score and decreases   overall postoperative analgesic consumption in patients given subarachnoid block with hyperbaric bupivacaine5. Higher dose of dexamethasone is superior to lower dose, although both prolongs analgesia and were effective in reducing postoperative opioid consumption.

       Various studies show that duration of sensory and motor block was significantly higher in patient receiving higher dose of intravenous dexamethasone as compared to lower dose5,6

      Lacunae in existing knowledge

However, to the best of our knowledge and also after searching quite a number of articles and extensive literature search, it has been found that no previous studies have compared the analgesic effect of two doses of intravenous dexamethasone, (0.15 mg/kg and 0.075 mg/kg) supplemented after subarachnoid block given with hyperbaric Bupivacaine in lower limb osteoarticular surgery. Therefore, we will compare the effects of two different doses of intravenous dexamethasone on postoperative pain in patients given subarachnoid block with 0.5% hyperbaric bupivacaine.

 

 
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