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CTRI Number  CTRI/2016/09/007238 [Registered on: 06/09/2016] Trial Registered Retrospectively
Last Modified On: 05/09/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Influence of three different techniques of anesthesia on chronic pain and functional outcome following open hernia repair 
Scientific Title of Study   Effect of three different anesthetic management techniques on Pain and Functional Outcome following Inguinal Hernia Surgery. A Randomized Controlled Observer blinded study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PG/2014/03, 25th January 2014, meeting held on 08/01/14  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof T Sivashanmugam 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University 
Address  Department of Anaesthesiology and Critical Care Mahatma Gandhi Medical College and Research Institute Sri Balaji Vidyapeeth University Pillayarkuppam

Pondicherry
PONDICHERRY
607403
India 
Phone  9442505567  
Fax  0413-2615457  
Email  drsiva95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hussain Ahmed M I 
Designation  Post graduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University 
Address  Department of Anaesthesiology and Critical Care Mahatma Gandhi Medical College and Research Institute Sri Balaji Vidyapeeth University Pillayarkuppam
Department of Anaesthesiology and Critical Care Mahatma Gandhi Medical College and Research Institute Sri Balaji Vidyapeeth University Pillayarkuppam
Pondicherry
PONDICHERRY
607403
India 
Phone  7708578056  
Fax  0413-2615457  
Email  mihussain87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof T Sivashanmugam 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University 
Address  Department of Anaesthesiology and Critical Care Mahatma Gandhi Medical College and Research Institute Sri Balaji Vidyapeeth University Pillayarkuppam

Pondicherry
PONDICHERRY
607403
India 
Phone  9442505567  
Fax  0413-2615457  
Email  drsiva95@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute Sri Balaji Vidyapeeth University Pillayarkuppam Pondicherry -607403 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical college and Research Institute 
Address  Professor and Head, Department of Anaesthesiology and Critical Care Pillayarkuppam, Pondicherry-607403 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr HUSSAIN AHMED MI  Post Graduate, Department of Anaesthesiology and Critical care, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Pillayarkuppam, Pondicherry -607403 
Dr Jaya V  Assistant Professor, Department of Anaesthesiology and Critical care Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth University, Pillayarkuppam, Pondicherry -607403 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof T Sivashunmugam  Mahatma Gandhi Medical College and Research Institute  Operation Theatre 4 & 5, Department of Anaesthesiology and Critical Care & Department of Surgery, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam Pondicherry -607403
Pondicherry
PONDICHERRY 		 9442505567
0413-2615457
drsiva95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing open hernioplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GA  Hernioplasty will be done under standard GA anesthetic technique and post operative analgesia will be provided with Inj. Paracetamol 1 gm, and Inj. Diclofenac sodium 50 mg IV 8th hourly on POD 0, followed by combination of Paracetamol 500 mg + Aceclofenac sodium 100 mg) twice a day, Tab. Pantaprazole 40 mg once daily from POD1 to POD 5. 
Comparator Agent  SAB  Open hernioplasty under single dose subarachnoid block using 3 ml of 0.5% Bupivacaine (H) and post operative analgesia using Inj. Paracetamol 1 gm, and Inj. Diclofenac sodium 50 mg IV 8th hourly on POD 0, followed by combination of Paracetamol 500 mg + Aceclofenac sodium 100 mg) twice a day, Tab. Pantaprazole 40 mg once daily from POD1 to POD 5 
Intervention  TAB  Open hernioplasy was done under single dose Subarachnoid block using 3ml 0.5% bupivacaine (H). Post operative analgesia was given with 20 ml of 0.25% bupivacaine every 8th hrly till POD3 using TAP catheter place under ultrasound guidance. They also receive Inj. Paracetamol 1 gm, and Inj. Diclofenac sodium 50 mg IV 8th hourly on POD 0, followed by combination of Paracetamol 500 mg + Aceclofenac sodium 100 mg) twice a day, Tab. Pantaprazole 40 mg once daily from POD1 to POD 5 as standard postoperative analgesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  All patients with ASA 1 & 2 status undergoing elective open hernioplasty 
 
ExclusionCriteria 
Details  Unwilling patients, patients who were not able to understand the COMI hernia assessment tool, laparoscopic procedures, patients who were allergic to the drugs used in this study were excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
COMI-Hernia Score was done using COMI-Hernia Assessment tool  preoperative and 6 month postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
Rest Pain relief was assessed using VAS score at rest   on the day of surgery and first 3 postoperative days at around 6 PM in the evening 
Dynamic Pain relief was assessed using VAS score at five specified activities- sitting, walking, climbing, during micurition and coughing  first 3 post operative days at around 6 PM in the evening 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The chronic postsurgical pain following hernioplasty is the most bothersome complication following simple open hernioplasty. Regional anesthesia with postoperative regional analgesia has been found to reduce chronic pain following mastectomy, thoracotmy and many other procedures. Hence, this study was designed to identify the effect of spinal anesthesia and post operative regional analgesia using TAP catheter on chronic pain and functional outcome following open hernioplasty.
 
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