| CTRI Number |
CTRI/2024/02/062949 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Post-operative pain relief techniques in inguinal hernia surgery. |
|
Scientific Title of Study
|
A prospective observational study to assess analgesic effect of ultrasound guided transverse abdominis plane (TAP) block and transmuscular quadratus lumborum (QL) block for post-operative pain relief in inguinal hernia surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brisha Modh |
| Designation |
2nd Year Anesthesia Resident |
| Affiliation |
New Surat Civil Hospital, Surat |
| Address |
Anaesthesia department 2nd floor New Civil Hospital, Majuragate, Surat,Gujarat.
Anaesthesia department 2nd floor New Civil Hospital, Majuragate, Surat,Gujarat.
Surat
GUJARAT
395001
India |
| Phone |
9408297181 |
| Fax |
|
| Email |
brishamodh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhavalkumar Patel |
| Designation |
Assistant Professor |
| Affiliation |
New Surat Civil Hospital, Surat |
| Address |
Anaesthesia department, 2nd floor, New Civil Hospital, Majuragate, Surat.
Anaesthesia department 2nd floor New Civil Hospital, Majuragate, Surat,Gujarat
Surat
GUJARAT
395009
India |
| Phone |
9898866862 |
| Fax |
|
| Email |
dcp991717@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhavalkumar Patel |
| Designation |
Assistant Professor |
| Affiliation |
New Surat Civil Hospital, Surat |
| Address |
Anaesthesia department, 2nd floor, New Civil Hospital, Majuragate, Surat.
Anaesthesia department 2nd floor New Civil Hospital, Majuragate, Surat,Gujarat
Surat
GUJARAT
395009
India |
| Phone |
9898866862 |
| Fax |
|
| Email |
dcp991717@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college and New Civil Hospital,Surat |
|
|
Primary Sponsor
|
| Name |
Government Medical College and New Civil Hospital, Surat |
| Address |
New Civil Hospital, Majuragate,
Surat |
| Type of Sponsor |
Government 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 Brisha Modh |
New Civil Hospital,Surat,Gujarat |
Second Floor OT Complex,Surgery operation theatre and Post-Operative Recovery Room, New Civil Hospital, Majura gate, Surat, Gujarat.
Surat
GUJARAT |
9408297181
brishamodh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee of GMC Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA Class I - III undergoing unilateral open inguinal hernia repair surgery under spinal anesthesia.
2) Patient who gives informed and written consent to collect data |
|
| ExclusionCriteria |
| Details |
1) Obese BMI greater than 35
2) Patient already taking analgesic for chronic pain
3) Laproscopic hernia
4) Bilateral hernia or obstructed hernia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS Score |
Initial 24hr[At different time interval 0hr, 2hr, 6hr, 24hr after block] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesics |
1 st 24 hours |
| Hemodynamic changes |
1st 24 hours |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/03/2024 |
| 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="1"
Months="6"
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 repair is common surgical procedure, but it often accompanied by acute to chronic post-operative discomfort. Postoperative pain is associated with post-operative complications like delayed rehabilitation, reduced level of function and quality of life. [3] ⮚ Conventionally, opioids have been used to manage postoperative pain. However, opioid related adverse events including vomiting, respiratory depression, paralytic ileus and sedation have shift towards opioid sparing techniques for postoperative analgesia. ⮚ Few regional analgesic techniques like transversus abdominis plane (TAP) block, transmuscular quadratus lumborum (QL) block, Epidural analgesia, Lumber plexus block are used for postoperative pain relief for lower abdominal surgeries. [1] ⮚ Here, at our anesthesia department we are using conventional analgesia (iv/im) and various nerve blocks for postoperative pain relief for open hernia repair surgery. ⮚ The main goal of postoperative pain management is to keep drug doses as low as possible to reduce adverse effects. The transversus abdominis plane (TAP) and transmuscular quadratus lumborum (QL) blocks are regional anaesthesia techniques that provides analgesia in various lower abdominal surgeries. Some of the anaesthesia consultants prefer to give TAP block while some of them use QL block after open hernia surgery. [2] So, we are going to do a prospective observational study to evaluate the analgesic effect of both the techniques on acute postoperative hernia surgery pain |