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CTRI Number  CTRI/2024/03/063850 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of 0.25%Ropivacaine versus 0.25%Ropivacaine with Dexmeditomedine in Ultrasound guided Transverse Abdominis Plane Block for Postoperative analgesia in inguinal hernia surgeries. 
Scientific Title of Study   A Comparative study to assess the efficacy of 0.25%Ropivacaine and 0.25%Ropivacaine with Dexmeditomedine in Ultrasound guided Transverse Abdominis Plane Block for Postoperative analgesia in unilateral open inguinal hernia surgeries under General Anaesthesia. 
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 Likhitha H 
Designation  Postgraduate Resident 
Affiliation  Bangalore Medical College and Research Institute  
Address  Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  8861436599  
Fax    
Email  likhitha1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrMadhumala H R 
Designation  Assisstant Professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  9886786768  
Fax    
Email  drmadhumala@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMadhumala H R 
Designation  Assisstant Professor 
Affiliation  Bangalore Medical College and Research Institute  
Address  Departmet of Anaesthesiology Bangalore Medical College and Research Institute Bangalore.

Bangalore
KARNATAKA
560002
India 
Phone  9886786768  
Fax    
Email  drmadhumala@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute  
Address  Bangalore Medical College and Research Institute,KR Road ,Fort, Bangalore -560002 
Type of Sponsor  Government 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 Madhumala H R  Bangalore Medical College and Research Institute  Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road,Fort,Bangalore-560002
Bangalore
KARNATAKA 		 09886786768

drmadhumala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K40||Inguinal hernia, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.25%Ropivacaine  15ml of 0.25%Ropivacaine will be administered with 1ml normal saline for ultrsound guided Transverse Abdominis Plane block (single dose)through anterior abdominal wall, for postoperative analgesia (observed for 24hours) in unilateral inguinal hernia surgeries.  
Comparator Agent  0.25%Ropivacaine and Dexmedetomedine   15ml of 0.25%Ropivacaine with 0.5mcg per kg Dexmeditomedine diluted with normal saline to 1ml will be administered for ultrsound guided Transverse Abdominis Plane block(single dose),through anterior abdominal wall for postoperative analgesia(observed for 24hours) in unilateral inguinal hernia surgeries 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologists (ASA1 and ASA2)
Patients being operated for elective unilateral inguinal hernia under general anaesthesia. 
 
ExclusionCriteria 
Details  Patients not willing to give informed consent
Patients with known allergy to any of study drug
Recurrent inguinal hernia patients
Emergency surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess postoperative analgesia using VAS score   To assess the VAS score at 1,3,6,12,24 hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Time of first dose of rescue analgesia  Time of requirement of first dose of Tramadol 2mg per kg body weight 
Total opiod requirement(Tramadol).  Total opioid requirement(Tramadol) in 24 hours. 
Degree of sedation.  Degree of sedation using Modified Wilsons score at 1,3,6,12,18,24 hours postoperatively. 
To assess Hemodynamic parameters Heart rate and Mean Arterial Pressure post operatively.  To assess the Hemodynamic parameters Heart rate and Mean Arterial pressure at 1,3,6,12,18 hours post operatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 4 
Date of First Enrollment (India)   18/03/2024 
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="2"
Months="0"
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   Hernia of abdominal wall are quite common having a prevalence of 1.7%for all ages and 4% for those older than 45years. Inguinal hernia repair (IHR) is one of the most common surgery, it is associated with 60% incidence of moderate to severe postoperative pain. Inguinal hernia repair is a relatively short and simple procedure. However, patients may experience moderate-to-severe post-operative pain that can affect their functional status and overall quality of life, which is of considerable concern who are at high risk for chronic pain, post-operative delirium (POD) and other post-operative complications. Ultrasonography-guided Transverse Abdominis Block is an effective peripheral abdominal field block ,which involves injecting local anesthetics into plane between internal oblique and transversus abdominis muscle ,where the intercostal ,subcostal,iliohypogastric ,ilioinguinal and genitofemoral nerve ,primarily innervate the lower abdominal wall. .TAP block provides significant analgesic effect especially below T10 upto L1 level,hence it is used in lower abdominal and gynecological surgeries. Ropivacaine is most commonly used local anesthetic for peripheral nerve block due to its prolonged duration of action,differential blockade and lesser cardiac toxicity.6 Dexmedetomidine is a selective alpha-2 adrenergic agonist with both analgesic and sedative properties. When administered as a perineural adjuvant, dexmedetomidine reduces initial blocking time while prolonging sensory and motor blockade duration.In this study we are comparing between 0.25%Ropivacaine and 0.25%Ropivacaine with Dexmedetomidine in Transverse Abdominis Plane block for unilateral inguinal hernia surgeries, in terms of efficacy and duration of analgesia. 
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