FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/038501 [Registered on: 08/12/2021] Trial Registered Prospectively
Last Modified On: 12/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of nerve block on the incidence of chronic pain in open inguinal hernia surgery  
Scientific Title of Study   Effect of Ultrasound-guided Ilioinguinal-Iliohypogastric Nerve Block on Chronic Pain in Patients undergoing open Inguinal Hernia surgery under Spinal Anesthesia: A Randomized Double blind pilot study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra Sahoo 
Designation  Senior consultant, Pain & Palliative care 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Trident Galaxy Kalinga Nagar Bhubaneswar Odisha India
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024
Khordha
ORISSA
751003
India 
Phone  7750008259  
Fax  916742725415  
Email  rajendra.sahoo@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Sahoo 
Designation  Senior consultant, Pain & Palliative care 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Trident Galaxy Kalinga Nagar Bhubaneswar Odisha India
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024

ORISSA
751003
India 
Phone  7750008259  
Fax  916742725415  
Email  rajendra.sahoo@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra Sahoo 
Designation  Senior consultant, Pain & Palliative care 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Trident Galaxy Kalinga Nagar Bhubaneswar Odisha India
Kushabhadra Campus(KIIT Campus)Patia Bhubaneswar Khurda, Odisha 751024

ORISSA
751003
India 
Phone  7750008259  
Fax  916742725415  
Email  rajendra.sahoo@kims.ac.in  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Primary investigator 
Address  Trident Galaxy, Kalinga Nagar, Bhubaneswar, Odisha, 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 
Dr Rajendra Sahoo  Kalinga Institute of Medical Sciences  Department of anesthesiology and pain management, third floor, KIMS, Kushabhadra Campus(kiit Campus-5) Patia Bhubaneswar 751024
Khordha
ORISSA 		 7750008259

rajendra.sahoo@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , KALINGA INSTITUTE OF MEDICAL SCIENCES(KIMS), KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR 751024  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, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% normal saline  Ultrasound- guided Ilioinguinal Iliohypogastric nerve block with 11 ml of 0.9% normal saline will be given once in the preoperative area followed by Spinal anesthesia with 3ml of 0.5% Bupivacaine inside the operation theatre.We will follow up the patients for 24hour in the postoperative period and upto 3 monts post surgery 
Intervention  Ropivacaine 0.5% and Dexamethasone 4mg(1ml)   Ultasound-guided Ilioinguinal ILiohypogastric Nerve block with 10ml of 0.5% ropivacaine and 4mg(1ml) dexamethasone will be given once in the preoperative area followed by spinal anesthesia with 3ml of 0.5% bupivacaine in side the operation theatre.then we will follow up the patients for 24 hour in the postoperative period and upto 3monts post surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Patients of American Society of Anesthesiologists Physical status (ASA) I-III posted for elective open unilateral inguinal hernia surgery under spinal anesthesia who agree to participate in the study. 
 
ExclusionCriteria 
Details  Patients with mental retardation and communicable disorder, infection at the injection site, contraindication to a nerve block, B/L or recurrent inguinal hernia or with hydrocele will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
•chronic inguinal pain by NRS and DN4 score at 3 months after surgery.
•Postoperative pain score according to numerical rating scale (NRS) at 3, 6,12 and 24 hours after surgery

• Total opioid consumption (in mg) in first-24 hours of postoperative period.
 		 -3,6,12 and 24 hours after surgery.
-3 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
•Time to first rescue analgesic (Tramadol) request by the patient
•Total opioid consumption (in mg) in first-24 hours of postoperative period
•Postoperative complications like nausea,vomiting, local anesthetic complications or neurological complications
 		 -24 hours postoperative period 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2021 
Date of Study Completion (India) 30/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Postherniorrhaphy groin pain is defined as pain lasting greater than 3 months after hernia surgery, which is one of the most important complications occurring after inguinal hernia repair.The overall incidence has been reported to be as high as 35% with an average of 10% patients reporting their pain as moderate to severe intensity. Preemptive regional nerve block (ilioinguinal & Iliohypogastric) has been found to reduce severity of acute postoperative pain and opioid consumption. However, its role in prevention of chronic pain is unclear. We hypothesize that  Ultrasound-guided ilioinguinal iliohypogastric nerve block has the potential to reduce the incidence of chronic groin pain at 3 months. 
Close