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CTRI Number  CTRI/2024/10/076060 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ultrasound guided nerve block vs standard pain relief after inguinal hernia surgery :A study on post surgery pain management. 
Scientific Title of Study   Comparison Between Ultrasound Guided Transversalis Fascia Plane block and Standard Wound Infiltration Technique On Postoperative Pain management in Patients with Inguinal Hernia Surgery- A Randomised Controlled Trial.  
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gour kishore Chakraborty 
Designation  Post graduate student 
Affiliation  IMS AND SUM HOSPITAL 
Address  Department of anesthesiology ims and sum hospital bhubaneswar odisha

Khordha
ORISSA
751003
India 
Phone  7980214768  
Fax    
Email  arghachakraborty6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Daisy Karan 
Designation  Professor 
Affiliation  IMS AND SUM HOSPITAL 
Address  Department of anesthesiology ims and sum hospital bhubaneswar odisha

Khordha
ORISSA
751003
India 
Phone  9348417449  
Fax    
Email  daisykaran@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Gour kishore Chakraborty 
Designation  Post graduate student 
Affiliation  IMS AND SUM HOSPITAL 
Address  Department of anesthesiology ims and sum hospital bhubaneswar odisha

Khordha
ORISSA
751003
India 
Phone  7980214768  
Fax    
Email  arghachakraborty6@gmail.com  
 
Source of Monetary or Material Support  
Ims And Sum Hospital Bhubaneswar. Kalinganagar,Bhubaneswar,Odisha, 751003 
 
Primary Sponsor  
Name  Ims And Sum Hospital Bhubaneswar 
Address  Kalinganagar, Bhubaneswar, Odisha 751003 
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 Gour Kishore Chakraborty  Ims And Sum Hospital.  Department of Anesthesiology . Room Number 501, PG Boys Hostel 3, Campus 2, SOA University. Bhubaneswar , Odisha, 751003.
Khordha
ORISSA 		 07980214768

arghachakraborty6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IMS AND SUM HOSPITAL  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 
Comparator Agent  Standard wound infiltration technique  Under proper aseptic conditions, patients had standard wound infiltration with 15 ml Ropivacaine 0.2%. In both groups, 15 cc of Bupivacaine 0.25% (AstraZeneca, Sweden) by a 23 G spinal needle was administered. Pain severity was assessed using the Visual Analogue Scale (VAS) at rest and while walking at 0, 2, 4, 6, 12, 24, 36 hours after surgery with 0 considered as no pain and 10 as the worst possible pain. satisfaction was measured using the Likert scale as poor, moderate, good, very good, and excellent. In patients requesting analgesics after surgery, time after block to the first request for analgesic and total diclofenac sodium injection requirement in 36 hours post- surgery .  
Intervention  Ultrasound Guided Transversalis Fascia Plane block and Standard Wound Infiltration Technique  Routine preanesthetic examination along with all the routine investigations of the patients will be performed spinal anesthesia was administered at the level of L4 to L5 interspace in sitting position, using a midline or paramedian approach, by a 25 G Quincke’s spinal needle. 2.6 milliliters of Bupivacaine 0.5% was injected at a rate of approximately 2 mL/second, and then all patients have lied on the supine position In TFP block, the probe was placed in transverse position, above the iliac crest. After visualization of internal oblique, external oblique, and transverse abdominis muscles, they were followed until the transverse abdominis and internal oblique reached the aponeurosis. After the tip of the needle was visualized between transverse abdominis and beneath fascia, ropivacaine was injected Pain severity was assessed using the Visual Analogue Scale (VAS) at rest and while walking at 0, 2, 4, 6, 12, 24, 36 hours after surgery with 0 considered as no pain and 10 as the worst possible pain  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age 15-60 years
Pateints under ASA I and ASA II
Elective inguinal hernia surgery
Under spinal anaesthesia
Non recurrent hernia surgeries 
 
ExclusionCriteria 
Details  patients refusal
patient age above 60 and less than 15
patient under asa 3 and 4
mallappati grading 3 and 4
patient having allergy to bupivacine
patient having coagulopathies 
 
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 Time to rescue analgesia
Post op pain at rest and movement by VAS Scores /Dynamic VAS Scores 		 0,2,4,6,12,24,36 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare patient satisfaction score (Linkert Scale).
Total Diclofenac sodium injection requirement .
 		 0 to 36 hours postoperatively 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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 3 
Date of First Enrollment (India)   24/11/2024 
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="5"
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   In this study 106 patients age between 15 to 60 years posted for inguinal hernia surgery.
Routine evalutions and investivations performed, patients are kept npo for 8 hours for solids and 4 hr for liquids. informed consent is obtined.

upon arrival in the oparating theater, standard ASA monitoring ( ECG, NIBP,SPO2). is establised. An 18 gauge IV cannula in inserted under aseptic condition  and ringer lactate infusion is started 5 ml /kg BW. Baseline vitals are recorded.

spinal anesthesia is administered at L4-L5 interspace using 25 G Quincke’s needle, with 2 ml of Bupivacaine 0.5% injected at arate of 2 ml/ second .

patient and outcome assessors are blinded to group allocation, with randomization done using computer generated numbers.

statistical analysis will be done by SPSS. sample size 106. in two group independent t test will be performed. p<0.5 is consider significant.

standard wound infiltration with 15 ml ropivacaine 0.2% or a TFP block is performed for TFP block ropivacaine in injected under USG guidance.

pain severity is evaluated by visual analogue scale (VAS) at specific time points post surgery . patient satisfaction is measured on a Linkert scale. Analgesic requests and total Diclofenac sodium requirements are recorded over 36 hours post surgery.
 
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