| 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
|
|
|
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
|
|
|
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.
|