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CTRI Number  CTRI/2024/11/076399 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of effectiveness of erector spinae plane block and transverses abdominis plane block in inguinal hernia repair  
Scientific Title of Study   A study to compare effectiveness of erector spinae plane block and transverses abdominis plane block in inguinal hernia repair for post operative analgesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sweta Gajapure  
Designation  Junior Resident  
Affiliation  Acharya Vinobha Bhave Rural Hospital,JNMC 
Address  Department of Anaesthesiology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha, Maharashtra, India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8625966945  
Fax    
Email  shwetagajapure@gmil.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Chakole 
Designation  HOD,Professor,Department of Anaesthesia,JNMC 
Affiliation  Acharya Vinobha Bhave Rural Hospital,JNMC 
Address  Department of Anaesthesiology,Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha, Maharashtra, India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  7583836564  
Fax    
Email  drvivekchakole@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Sweta Gajapure  
Designation  Junior Resident  
Affiliation  Acharya Vinobha Bhave Rural Hospital,JNMC 
Address  Department of Anaesthesiology,Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe),Wardha, Maharashtra, India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  8625966945  
Fax    
Email  shwetagajapure@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College Sawangi Meghe Wardha Maharashtra India  
Address  Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra, India 442001 
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 Sweta Gajapure  Acharya Vinobha Bhave Rural Hospital  Department of Anaesthesiology,JNMC,Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe),Wardha,India,442001
Wardha
MAHARASHTRA 
8625966945

shwetagajapure@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional ethics committee  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 
Intervention  ESP Block  Ultrasound-guided Erector spinae plane (ESP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient- controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed 
Comparator Agent  TAP Block  Ultrasound-guided Transversus abdominis plane (TAP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patients of either sex, aged between 18-70 years belonging to American Society of Anaesthesiologists (ASA) physical status I and II posted for hernioplasty were included in the study.  
 
ExclusionCriteria 
Details  • Patient refusal .
• Contraindications to regional anesthesia
• Known allergy to local anesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Inability to provide informed consent
• Severe kidney or liver disease
• Inability to operate PCA system • Patient with psychiatric disorders
• Patients with ASA grade IV.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Is to compare the post operative analesia of ultrasound
guided Erectorspinae plane block with Transverse abdominis plane block in inguinal
hernia repair. 
24 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
is to compare
1.Haemodynamic stability
2.Number of failure of block with both techniques
3.Complications following blocks 
24 HOURS 
 
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   Phase 2 
Date of First Enrollment (India)   16/11/2024 
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="2"
Months="0"
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   Inguinal hernia surgery is one of the commonly performed surgical procedures worldwide, which is associated with substantial postoperative pain and distress requiring effective analgesia. Multimodal analgesia is used to control postoperative pain in inguinal hernia repair. Transversus abdominis plane (TAP) block is one of the approaches to provide effective postoperative analgesia in patients undergoing hernia surgeries. The erector spinae plane(ESP) block is a recently described regional anaesthesia technique, when applied to low thoracic region was reported to provide extensive, potent unilateral analgesia in these surgeries by acting on both dorsal and ventral branches of thoracic spinal nerves. In this study, we aimed to determine and compare the effect of transversus abdominis plane block and erector spinae plane block on postoperative pain in patients undergoing inguinal hernia repairs under subarachnoid block. 

PRIMARY OBJECTIVE: Is to compare the post operative analgesia of ultrasound guided Erectorspinae plane block with Transverse abdominis plane block in inguinal hernia repair. 

SECONDARY OBJECTIVE; is to compare 
1.Haemo dynamic stability
2.Number of failure of block with both techniques 
3.Complications following blocks

METHODOLOGY:
A brief history and detailed general examination will be performed in all participants. Consent will be duly signed. All the patients will be kept overnight fasting of 8 hours prior to the scheduled day of surgery. Once the patient is received in the preoperative area, vital parameters such as respiratory rate, heart rate, saturation of oxygen (SpO2), blood pressure and ECG changes will be monitored and noted. Intravenous line will be secured with either 20G or 18G IV cannula. The selected patients will be randomly assigned to two subsequent groups, n=30 each, based on a computer randomization.
Active Comparator: ESP Block Ultrasound-guided Erector spinae plane (ESP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patientcontrolled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed Procedure: ESP Block ESP block will be performed at the finishing of surgery under spinal anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-3 cm lateral to T10 spinous process. The erector spinae muscles will be identified superficial to the tip of T10 transverse process. The patient’s skin will be anesthetized with 2% lidocaine. A 22-gauge 10- cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of bupivacaine/lidocaine mixture will be injected. Other: Standard Pain Followup and Monitorization Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.- 24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation. TAP Block Ultrasound-guided Transversus abdominis plane (TAP) block will be performed at the finishing of the surgery with 30 ml of a bupivacaine/lidocaine mixture. The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed Procedure: TAP Block TAP block will be performed at the finishing of surgery under spinal anesthesia. A linear ultrasound transducer will be placed to lateral aspect of abdomen. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane between transversus abdominis and internal oblique muscles..A total of 30 mL of bupivacaine/lidocaine mixture will be injected Sham Comparator: Control The postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. Other: Standard Pain Followup and Monitorization Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.- 24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.


 
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