| CTRI Number |
CTRI/2021/09/036895 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| 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
|
Comparison between different nerve blocks for postoperative pain in inguinal hernia surgery. |
|
Scientific Title of Study
|
Ultrasound guided transversus abdominis plane block versus ilioinguinal and iliohypogastric nerve block versus local infiltration for postoperative analgesia in inguinal hernia surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Kumari |
| Designation |
Resident Doctor |
| Affiliation |
Teerthanker mahaveer medical College and research centre |
| Address |
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7906307174 |
| Fax |
|
| Email |
nehaadhana01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Shahbaz Alam |
| Designation |
Associate professor |
| Affiliation |
Teerthanker mahaveer medical College and research centre |
| Address |
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Kumari |
| Designation |
Resident Doctor |
| Affiliation |
Teerthanker mahaveer medical College and research centre |
| Address |
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7906307174 |
| Fax |
|
| Email |
nehaadhana01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Department of Anaesthesia Teerthanker mahaveer medical college and research centre
Moradabad,UP |
| 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 Neha Kumari |
Teerthanker mahaveer medical college and research centre |
Department of Anaesthesia
Teerthanker mahaveer medical college and research centre
Moradabad UP
Moradabad
UTTAR PRADESH |
7906307174
nehaadhana01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ilioinguinal and iliohypogastric nerve block for postoperative analgesia in inguinal hernia surgery. |
Ilioinguinal and iliohypogastric nerve block for postoperative analgesia in inguinal hernia surgery. |
| Comparator Agent |
Local infiltration for postoperative analgesia in inguinal hernia surgery. |
Local infiltration for postoperative analgesia in inguinal hernia surgery. |
| Intervention |
Transversus abdominis plane (TAP) block for post operative analgesia in inguinal hernia surgery |
Transversus abdominis plane (TAP) block for post operative analgesia in inguinal hernia surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
American society of Anaesthesiology physical status I and II
Surgery lasting for< 2hr
Patient with BMI 18.5-22.9kg/m2
|
|
| ExclusionCriteria |
| Details |
Patients who refused to consent to the study.
Skin infection at the puncture site.
Hypersensitivity to LA agents.
Pregnancy
Preoperative opioid or non-steroidal
anti-inflammatory drugs treatment for chronic
pain.
Contraindication to subarachnoid block
(SAB).
Patient requiring supplementary analgesics or
conversion to G.A. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the quality of postoperative analgesia using Visual Analogue Scale
(VAS) of transversus abdominis plane block versus ilioinguinal and iliohypogastric
nerve blocks USG guided versus local infiltration. |
VAS scores will be assessed at 0, 15mins, 30mins, 1, 2, 4, 6, 10, 14, 18, and 24
hours, where the time 0 at the start of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamics will be assessed intraoperatively, first rescue analgesia requirement and total analgesic requirement in 24 hrs. |
Hemodynamics will be assessed intraoperatively at 0min, 1min, 5, 10, 15, 20,
30, 40, 50, 60, 75, 90, 120mins. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients undergoing inguinal hernia repair experience severe pain in postoperative period especially during first 24hrs. Many approaches or multi modal techniques can be used to minimize pain. One such method is to supplement iv analgesics with nerve blocks or local infiltration.
Nerve blocks will provide analgesia and also lessen the requirement of I v. analgesics in terms of doses and frequency of administration, thereby minimizing side effects of the latter.
Aim: To compare the effectiveness of USG guided transversus abdominis plane(TAP) block versus USG guided ilioinguinal and iliohypogastric nerve blocks versus local infiltration in herniorrhaphy for postoperative analgesia.
Objectives:
To assess the duration of post operative analgesia in USG guided transversus abdominis plane block.
To assess the duration of post operative analgesia in USG guided ilioinguinal and iliohypogastric nerve block.
To assess the duration of post operative analgesia with wound infiltration at proposed site of incision.
To compare the quality of postoperative analgesia using Visual Analogue Scale (VAS) of transversus abdominis plane block versus ilioinguinal and iliohypogastric nerve blocks USG guided versus local infiltration.
METHODOLOGY Each patient will be explained the entire procedure and purpose in his/her language. Written informed consent for the procedure will be taken.
The subarachnoid block will be administered in sitting position with 25G Quincke needle at either L2-L3 or L3-L4 space.
Randmonisation by chit and box method. Group T: Transverse abdominis plane block using 20ml of 0.25% bupivacaine with 5mcg/ml adrenaline OR
Group I: Ilioinguinal/iliohypogastric nerve Block -10ml 0.25% Bupivacaine in ilioinguinal and10ml 0.25% Bupivacaine in iliohypogastric with 5mcg/ml adrenaline. Total volume 20ml OR
Group L: Infiltration of incision site with 20ml of 0.25% bupivacaine with 5mcg/ml adrenaline
VAS scores will be assessed at 0, 15mins, 30mins, 1, 2, 4, 6, 10, 14, 18, and 24 hours, where the time 0 at the start of the surgery.
Hemodynamics will be assessed intraoperatively at 0min, 1min, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120mins.
Postperatively patient will be given Inj. PCM 1mg IV infusion as first rescue analgesia and then it will be continued 8 hourly.
After collection of the data, appropriate statistical test will be applied and conclusion will be drawn
|