FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037784 [Registered on: 03/11/2021] Trial Registered Prospectively
Last Modified On: 07/10/2024
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 opioids in spinal anesthesia. 
Scientific Title of Study   COMPARATIVE STUDY OF DURATION OF ANALGESIA OF TRAMADOL VERSUS NALBUPHINE ADDED TO INTRATHECAL BUPIVACAINE IN SPINAL ANAESTHESIA FOR INFRAUMBILICAL SURGERIES. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhaghawathy B 
Designation  PG 
Affiliation  Sree Balaji Medical College and Hospital, Chennai, India. 
Address  Dept of Anesthesiology Sree Balaji Medical College and Hospital BIHER 7 Works Road New colony Chromepet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9489529369  
Fax    
Email  bhahaboj1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhaghawathy B 
Designation  PG 
Affiliation  Sree Balaji Medical College and Hospital, Chennai, India  
Address  Dept of Anesthesiology Sree Balaji Medical College and Hospital BIHER 7 Works Road New colony Chromepet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9489529369  
Fax    
Email  bhahaboj1995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raghuraman MS 
Designation  Prof of Anesthesiology 
Affiliation  Sree Balaji Medical College and Hospital, Chennai, India  
Address  Dept of Anesthesiology, Sree Balaji Medical College Hospital BIHER 7 Works Road New colony Chromepet Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9486837256  
Fax    
Email  drraghuram70@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anesthesiology,Sree Balaji Medical College Hospital, Chennai, India 
 
Primary Sponsor  
Name  Sree Balaji Medical College Hospital 
Address  #7, Works Road, New colony, Chromepet. Chennai – 600044. INDIA.  
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 
Bhaghawathy  Sree Balaji Medical College & Hospital   Dept of Anesthesiology, Third Floor OT Complex, #7, Works Road, New colony, Chromepet. Chennai – 600044. INDIA.
Chennai
TAMIL NADU 		 9489529369

bhahaboj1995@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 
Intervention  Group 1  Group 1 - Inj. Tramadol 25 mg (0.5 ml) added to 0.5 % hyperbaric bupivacaine 2.5ml  
Comparator Agent  Group 2  Group 2 - Inj. Nalbuphine 1 mg (0.1 ml)+ NS 0.4 ml added to 0.5 % hyperbaric bupivacaine 2.5ml  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.All elective infraumblical surgeries
2.ASA grade - I, II
 
 
ExclusionCriteria 
Details  1.Patient refusal.
2.ASA grade – III OR Above
3.Patients with complications like severe anaemia,
hypovolemia, septicaemia, shock, spinal column
abnormalities, previous spine surgery.
4.Any contraindication to regional anaesthesia and
with a known history of allergy to local
anaesthetics / radio‐opaque dye.
5.Bleeding disorders or on anticoagulant therapy,
Congenital or acquired coagulation disorders.
6.Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia  Intrathecal administration of drugs is considered as baseline. From that time, this will be assesses every hourly until the first request of analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of sensory block
2. Duration of motor block 		 1.Intrathecal administration of drugs is considered as baseline. From that time this will be assessed every hourly until the first request of analgesia
2. Every hourly from the time of achievement of Grade 3 motor block to Grade 0 motor block  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/11/2021 
Date of Study Completion (India) 30/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 We completed the study and started the publication process. 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 [bhahaboj1995@gmail.com].

  6. For how long will this data be available start date provided 26-10-2022 and end date provided 26-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 This study was taken up to compare the commonly used opioids namely Tramadol and Nalbuphine as an adjuvant to spinal bupivacaine. Although these two drugs are safe and commonly used, only a few studies compared these two drugs.

We observed that nalbuphine was better than tramadol.
 
Close