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CTRI Number  CTRI/2020/07/026566 [Registered on: 14/07/2020] Trial Registered Prospectively
Last Modified On: 08/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two different ultrasound guided nerve block for post operative pain relief in inguinal hernia surgeries 
Scientific Title of Study   COMPARISON OF ULTRASOUND GUIDED LUMBAR ERECTOR SPINAE BLOCK WITH TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POST-OPERATIVE ANALGESIA IN INGUINAL HERNIA REPAIR: A RANDOMISED CONTROL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen R Nandaragi 
Designation  1st year PG student 
Affiliation  S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot 
Address  Department of Anaesthesia, S N Medical college, Bagalkot.

Bagalkot
KARNATAKA
587102
India 
Phone  9916588994  
Fax    
Email  nandaraginaveenr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal 
Designation  Professor 
Affiliation  S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot 
Address  Department of Anaesthesia, S N Medical college, Bagalkot.
B 24, SN Medical college staff quarters,Bagalkot 587102
Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Naveen R Nandaragi 
Designation  1st year PG student 
Affiliation  S Nijalingappa Medical College and Research Institute, HSK Hospital, Bagalkot 
Address  Department of Anaesthesia, S N Medical college, Bagalkot.


KARNATAKA
587102
India 
Phone  9916588994  
Fax    
Email  nandaraginaveenr@gmail.com  
 
Source of Monetary or Material Support  
S N Medical college and HSK hospital,Bagalkot  
 
Primary Sponsor  
Name  S N Medical college and HSK hospital 
Address  Navanagar,Bagalkot 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Naveen R Nandaragi  S N Medical college and HSK Hospital  Department of Anaesthesia, 1st floor, Major OT complex
Bagalkot
KARNATAKA 
9916588994

nandaraginaveenr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-INSTITUTE ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH  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  Erector spinae,TAP block  Comparing efficacy of post op analgesia of these blocks 1st post op day  
Intervention  Erector spinae,TAP block  Ultrasound guided for post op analgesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA I-II Patients.
2. Patients undergoing elective unilateral inguinal
hernia repair. 
 
ExclusionCriteria 
Details  1. Refusal at enrolment.
2. Patients with coagulation system disorders.
3. Patients with raised intra cranial tension.
4. Patients with fixed cardiac output states.
5. Patients with hepatic or renal failure.
6. Chronic use of opioids or corticosteroids.
7. Patients allergic to the drugs/ Local
anaesthetics to be used for the study
8. Infection at injection site
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of post operative analgesia will be assessed after giving ultrasound guided block   24 hours after the block 
 
Secondary Outcome  
Outcome  TimePoints 
None  not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   23/07/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Tulgar S et al,3conducted a study on 60 persons undergoing hip or proximal femur surgeries, aging between 18-65 years, belonging toASA grade I-III.Three groups were present in the study, namely Lumbar Erector Spinae Block (L-ESPB)group, Transmuscular Quadratus Lumborum Block (QLB-T) group and the Control group in which no block was performed. Blocks were given for better post-operative analgesia. Each group consisted of 20 patients each.Pain intensity between groups was compared using Numeric Rating Scores (NRS). The NRS scores at 1st, 3rd and 6th hours and the number of patients required rescue analgesic in 24 h were significantly higher in the control group compared to both block groups. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The benefits of good postoperative analgesia include reduction in the postoperative stress response and morbidity, better patient satisfaction, early ambulation, early discharge from post-operative care unit, early discharge in day care surgeries and improved outcome. And also adequate post-operative analgesia will reduce overall complications, including respiratory.

Most of the patients coming for inguinal hernia repair are in elderly age group, who deserve adequate post-operative analgesia. Because in these age group often they have other co morbidities like diabetes mellitus, hypertension.

Inguinal hernia repair can lead to significant post-operative pain. Non opioid analgesia techniques are especially important in aging populations when co-morbidities are considered.

Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute and postoperative pain. In this ultrasound-guided (USG) technique, local anesthetic is applied between the erector spinae muscle and the transverse process of the vertebra leading to spread of local anaesthetic cephalad, caudally and also through the paravertebral space.

The Transversus abdominis plane (TAP) block is an alternate, easy to perform, and an effectiveperipheral abdominal field block that blocks the ilioinguinal, hypogastric and lower intercostal(T7–T11) nerves. TAP block is a novel technique for blocking the abdominal wall neural afferents via the lumbar triangle of Petit.

This study is going to establish Effectiveness of LumbarErector Spinae Block (L-ESPB) and Transversus Abdominis Plane (TAP) blocks in post-operative analgesia after inguinal hernia repair, which will be going to help us practice good multimodal analgesia in the post-operative period.

 
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