FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076103 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
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 drugs for pain relief in hernia surgeries 
Scientific Title of Study   Comparison of efficacy of Nalbuphine-Levobupivacaine combination with Levobupivacaine alone in ultrasound guided Transversus Abdominis Plane block in open inguinal hernia repair surgeries : A randomised control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshi Singh 
Designation  PG resident  
Affiliation  Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand 
Address  Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand

Rajsamand
RAJASTHAN
313202
India 
Phone  9660550323  
Fax    
Email  drhimanshi31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sakshi 
Designation  Assistant professor 
Affiliation  Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand 
Address  Room no 2040, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand

Rajsamand
RAJASTHAN
313202
India 
Phone  9571241824  
Fax    
Email  drsakshiarora88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sakshi 
Designation  Assistant professor 
Affiliation  Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand 
Address  Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand


RAJASTHAN
313202
India 
Phone  9571241824  
Fax    
Email  drsakshiarora88@gmail.com  
 
Source of Monetary or Material Support  
Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand, Rajasthan, India PIN code 313202 
 
Primary Sponsor  
Name  Himanshi Singh 
Address  Room no 2040, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand 
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 Sakshi   Ananta institute of medical sciences and research centre   Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, Village Kaliwas, Nathdwara, Rajsamand
Rajsamand
RAJASTHAN 
9571241824

drsakshiarora88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ananta IEC  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  Levobupivacaine  20ml Levobupivacaine 0.25% +1 ml Normal Saline given in TAP block. 
Comparator Agent  Levobupivacaine with Nalbuphine  20ml Levobupivacaine 0.25% + 10mg (1ml) Nalbuphine given in TAP block 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Informed consent, all patients undergoing unilateral open inguinal hernioplasty, ASA class 1 and 2  
 
ExclusionCriteria 
Details  ASA grade III and IV, Allergy to the study drug, Communication difficulties being unable to comprehend visual analogue scale, Bleeding diathesis, Patients with deranged liver and kidney functions, BMI less than 18 and more than 35, Surgery duration of more than 2 hours  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the time of first rescue analgesic (duration of analgesia)
 
0 mintues, 30 min, 60 min, 90 min, 120 min, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the visual analogue score (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively, to observe the side effects  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)   04/11/2024 
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 - 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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drhimanshi31@gmail.com].

  6. For how long will this data be available start date provided 14-10-2026 and end date provided 14-01-2027?
    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  

Pain after open Hernia Repair surgeries can be moderate to severe and may be associated with prolonged hospital stay, increase in sympathetic activity leading to increase in heart rate, blood pressure, respiratory rate and even delirium. Transversus Abdominis Plane (TAP) Block is a recent modality used for postoperative analgesia with minimal side effects in Inguinal Hernia Repair surgeries. A local anaesthetic solution is deposited between the plane of Internal Oblique (IO) and Transversus Abdominis (TA) muscles. The  efficacy of Nalbuphine has been explored as an adjuvant to other drugs in central neuraxial blocks by epidural, caudal and intrathecal routes. But there is limited data of use of Nalbuphine in combination with Levobupivacaine in TAP block. So this study is planned to evaluate the analgesic efficacy of Nalbuphine with Levobupivacaine and Levobupivacaine alone in TAP block in hernia surgeries. The aim of the present study is to compare the analgesic efficacy of Nalbuphine with Levobupivacaine versus Levobupivacaine alone in  TAP block in Inguinal Repair Hernia surgeries. The objective is to assess the time of first rescue analgesic (duration of analgesia), to observe the visual analogue score (VAS)  (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively and to observe the side effects. 



 
Close