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CTRI Number  CTRI/2024/10/075564 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   EFFECT ON SENSORY BLOCK DURATION IN INGUINAL HERNIA PATIENTS OF 18 - 60 YEARS AFTER SPINAL ANAESTHESIA WITH BUPIVACAINE SUPPLEMENTED WITH DEXAMETHASONE 
Scientific Title of Study   Effect on sensory block duration after spinal anesthesia supplemented with intravenous Dexamethasone. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dibyanshu Shekhar Swain 
Designation  PG JR 
Affiliation  AIIMS Raipur  
Address  Department of Anesthesiology, 4th floor, B block OT complex, AIIMS Raipur, Chattisgarh
Gate No 5, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India 
Phone  7008960410  
Fax    
Email  swaindibyanshu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Khobragade 
Designation  Associate Professor 
Affiliation  AIIMS Raipur  
Address  Department of Anaesthesiology, 4th floor, B block OT complex, AIIMS, Raipur.
Gate No 5, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India 
Phone  9820961117  
Fax    
Email  drpradeepk1117@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dibyanshu Shekhar Swain 
Designation  PG JR 
Affiliation  AIIMS Raipur  
Address  Department of Anesthesiology, B block OT complex, AIIMS Raipur campus, Tatibandh, Raipur
Gate No 5, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India 
Phone  7008960410  
Fax    
Email  swaindibyanshu@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur , Gate No 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 
 
Primary Sponsor  
Name  Dibyanshu Shekhar Swain 
Address  Department of Anesthesiology, B block OT complex, AIIMS campus, Tatibandh, Raipur, Chhattisgarh 492099 
Type of Sponsor  Other [Self] 
 
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 Dibyanshu Shekhar Swain  All India Institute of Medical Sciences,Raipur   Gate No 5, Great Eastern Rd, opposite Gurudwara, All India Institute of Medical Sciences Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 		 7008960410

swaindibyanshu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K40-K46||Hernia, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone  Spinal Anesthesia with 3 ml of 0.5% bupivacaine(heavy) with 8 mg of dexamethasone(2ml) given intravenously  
Comparator Agent  Normal saline  Spinal anaesthesia with 3 ml of 0.5% bupivacaine(heavy) with 2ml normal saline given intravenously  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries. 
 
ExclusionCriteria 
Details  Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded. 
 
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 
Sensory block duration   Intra-operative period 
 
Secondary Outcome  
Outcome  TimePoints 
1) To determine the time taken to achieve highest level of sensory block.
2) To determine Time required to first rescue analgesia.
3) To determine the Effects on hemodynamics of the patient.
4) To find incidence of postop nausea & vomiting. 		 At baseline, every 5 min for up to 30 min & then every 15 min until two-dermatome regression from the highest dermatome blocked. 
 
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)   25/10/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swaindibyanshu@gmail.com].

  6. For how long will this data be available start date provided 10-06-2025 and end date provided 23-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
    The randomised, doubleblind interventional study will be conducted in the Department of Anaesthesiology at AIIMS,Raipur. After obtaining approval from Institutional Ethics Committee, this study will beconducted for 18 months in 60 American Society of Anaesthesiologists(ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries. Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded. All the patients who meet the inclusion criteria will be enrolled in the study and written informed consent will be obtained for the participation in the study 
    All patients will be made to fast according to the standard nil per oral guidelines. The patients will be randomised into two groups by a computergenerated randomisation list to receive either of the two regimens. [Figure 1] For the BD group, 3 ml of 0.5% bupivacaine(heavy) with 8 mg of dexamethasone(2ml)IV and for the BS group 3 ml of 0.5% bupivacaine(heavy) with 2ml normal saline IV was administered to keep the total volume the same in both groups.
    A doubleblinding technique will be followed, where an anaesthesiologist who is not part of the study will prepare the solution according to the allocated group. The solution will then be handed over to the investigator who will administer the spinal anaesthesia. The investigator will be unaware of the group allocation.
 
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