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CTRI Number  CTRI/2025/06/088360 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
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   Effectiveness of dexmedetomidine used as an adjuvant with ropivacaine for ultrasound-guided iliohypogastric, illioinguinal and genitofemoral nerve block for inguinal hernia repair surgery 
Scientific Title of Study   Evaluation of effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided iliohypogastric,ilioinguinal and genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair A randomised double blinded controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Idris Ezzy 
Designation  Post Graduate Student Anaesthesia  
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia, RNT Medical College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8233936212  
Fax    
Email  idrisezzy110@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Idris Ezzy 
Designation  Post Graduate Student Anaesthesia  
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia RNT Medical College Udaipur


RAJASTHAN
313001
India 
Phone  8233936212  
Fax    
Email  idrisezzy110@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Idris Ezzy 
Designation  Post Graduate Student Anaesthesia  
Affiliation  RNT Medical College Udaipur 
Address  Department of Anaesthesia RNT Medical College Udaipur


RAJASTHAN
313001
India 
Phone  8233936212  
Fax    
Email  idrisezzy110@gmail.com  
 
Source of Monetary or Material Support  
RNT Medical College Udaipur Rajasthan India Pin Code 313001 
 
Primary Sponsor  
Name  RNT Medical College 
Address  RNT Medical College Udaipur Rajasthan India pin code 313001 
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 Idris Ezzy  RNT Medical College  Department of Anaesthesiology 2nd floor
Udaipur
RAJASTHAN 
08233936212

idrisezzy110@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT Medical College and controller and Attached Hospitals Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine, Ropivacaine  Evaluation of effectiveness of Dexmedetomidine with ropivacaine  
Intervention  Regional Anaesthesia  Ultrasound Guided iliohypogastric, ilioinguinal and genitofemoral nerve block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. Patients with American Society of Anaesthesiologist (ASA) Physical Status (PS) 1 to 3

2. Duration of surgery less than 2 hours 
 
ExclusionCriteria 
Details  1. Patients who will not give consent.
2. Infection at the puncture site.
3. Patients with age lesser than 18 years and greater than 65 years
4. Patients with BMI greater than 35 kg per m2
5. Patients with history of allergy to local anaesthetic or dexmedetomidine
6. Patients with resting heart rate lesser than 50 per min.
7. Patients with history of unstable angina or myocardial infarction or complete heart block.
8. Patients with any known severe cardiac, respiratory, renal,or hepatic disease.
9. Patients with history of any psychiatric,neurological disease or seizure disorder.
10. Patients with history of bleeding disorders or deranged coagulation profile.
 
 
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 compare Duration of Analgesia in both the groups  Duration of analgesia is the time postoperatively when patient will demand for rescue analgesia or when patients VAS score is equal to or more than 4 in first 24 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Onset of sensory block  Immediately after block in minutes. 
To compare duration of sensory block  Assessed postoperatively in first 24 hrs 
To compare visual analog scale  Assessed postoperatively at 1 hr 2 hr 4 hr 6 hr 12 hr 18 hr 25 hr 
To compare total rescue analgesic consumption   postoperatively in first 24 hours 
To compare postoperatively patient satisfaction score  Assessed after completion of surgery 
To compare surgeon satisfaction score   Assessed after completion of surgery 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 2 
Date of First Enrollment (India)   25/06/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Inguinal hernioplasty is one of the most commonly performed surgical procedures all over the world. Subarachnoid block is routinely used as an anaesthetic technique of choice without much difficulties and adverse outcomes. However, certain comorbid conditions like ischaemic heart disease, valvular heart disease, coagulopathies, cardiomyopathy etc. increase the risk associated with and limits use of neuraxial blockade as a plan of anaesthesia. Bony deformities like kyphosis and scoliosis make subarachnoid block technically difficult and there is also unpredictable spread of local anaesthetic along subarachnoid space. In such scenarios, general anaesthesia remains the sole technique of choice to undergo planned surgery. This makes the patient bear a wide range of shortcomings like delayed recovery, intensive care unit (ICU) admission, mechanical ventilation, prolonged hospital stay with economic burden along with increased risk of morbidity and mortality.

Inguinal hernia block has wide range of advantages over general anaesthesia in patients with a compromised cardiac status and other co-morbidities. It avoids endotracheal intubation, polypharmacy and subsequent delayed recovery. Further, it decreases the need of ventilator support, provides adequate post-operative analgesia with reduced opioid requirement. The period of hospitalisation is also decreased thus reducing the economic burden. 

Ilioinguinal nerve block (IINB), iliohypogastric nerve block (IHNB) and genital branch of the genitofemoral (GF) nerve blocks completes the anaesthesia and may be used for inguinal hernia repair surgeries.Direct ultrasonographic visualisation of these nerves improves the quality of the block, increases success rate to 95 percent, and reduces the risk for complications.

With this background, the present study will be conducted to evaluate the effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided ilioinguinal, iliohypogastric and genital branch of genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair.

 
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