| CTRI Number |
CTRI/2024/03/063593 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess efficacy of steroid as adjuvant added to local anaesthetic in regional technique for pain management in laproscopic inguinal hernia repair- a randomized controlled prospective study |
|
Scientific Title of Study
|
To Compare the analgesic efficacy of Ropivacaine versus Ropivacaine with Dexamethasone for Post-operative analgesia in Ultrasound guided TAP ( Transversus Abdominis Plane) block for Laproscopic Inguinal Hernia repair-a randomized doube blind controlled prospective study |
| 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 Rajesh Kumar Harish |
| Designation |
Consultant |
| Affiliation |
Fortis Hospital, Mohali |
| Address |
Department of Anaesthesia,Fortis Hospital, Sahibzada Ajit Singh Nagar, Sector 62, Lamba, Mohali 160062
Chandigarh
CHANDIGARH
160062
India |
| Phone |
9417661053 |
| Fax |
|
| Email |
hearty2brainy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Harish |
| Designation |
Consultant |
| Affiliation |
Fortis Hospital, Mohali |
| Address |
Department of Anaesthesia, Fortis Hospital, Sahibzada Ajit Singh Nagar, Sector 62, Lamba, Mohali 160062
Chandigarh
CHANDIGARH
160062
India |
| Phone |
9417661053 |
| Fax |
|
| Email |
hearty2brainy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anmol Singla |
| Designation |
Junior Resident |
| Affiliation |
Fortis Hospital, Mohali |
| Address |
Department of Anaesthesia, Fortis Hospital, Sahibzada Ajit Singh Nagar, Sector 62, Lamba, Mohali 160062
Chandigarh
CHANDIGARH
160062
India |
| Phone |
7889209159 |
| Fax |
|
| Email |
anmolsingla50@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Fortis Hospital, Mohali |
| Address |
Department of Anaesthesia, Fortis Hospital, Mohali |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rajesh Kumar Harish |
Fortis Hospital |
Department of Anaesthesia,Fortis hospital,Sector 62,Sahibzada Ajit Singh Nagar,Mohali
Chandigarh
CHANDIGARH |
9417661053
hearty2brainy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Fortis Hospital,Mohali |
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 |
TAP block with Ropivacaine with Dexamethasone |
USG guided TAP block with Ropivacaine with Dexamethasone total volume 20ml + 2 ml in adult patients undergoing Laproscopic Inguinal hernia repair under general anaesthesia and pain will be scored according to VAS scale on 0,2,4,8,12,16,24 hrs |
| Comparator Agent |
TAP block with Ropivacaine with Normal saline |
USG guided TAP block with Ropivacaine with Normal saline total volume 20ml + 2 ml in adult patients undergoing Laproscopic Inguinal hernia repair under general anaesthesia and pain will be scored according to VAS scale on 0,2,4,8,12,16,24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
ASA Grade 1 & 2
Patients in age group of 18-65 years posted for laproscopic inguinal hernia surgery
Willing to participate |
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy or contraindication to study medicine
ASA Grade 3 & 4
Drug or Alcohol abuse
Surgery converted to open procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the time of First rescue analgesia post-operatively
Evaluate total doses of rescue analgesia in 24 hrs |
VAS scores will be assessed at 0hr,2hr,4hr,8hr,12hr,16hr,24hr
Total dose of rescue analgesia will be assessed in 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate efficacy of TAP block in providing post-operative analgesia in laproscopic inguinal hernia surgeries
Evaluate safety and adverse effects of TAP block
Assess pain severity using Visual Analogue score(VAS score)
Post-operative opioid consumption |
0hr,2hr,4hr,8hr,16hr,24hr |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
14/03/2024 |
| 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="0"
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
|
Laproscopic surgeries are commonly performed surgical procedures and these patients require a multi-modal post-operative pain treatment regimen. Regional anaesthesia techniques have shown to decrease consumption as well as its adverse effects. Transversus Abdominis Plane (TAP) block is a regional anaesthesia technique that has been applied in multi-modal pain regimen in laproscopic and open abdominal surgeries for reduction in pain scores and opioid use,reduced incidence of post operative nausea and vomiting has also been noted.
Dexamethasone is a corticosteroid which has been used here owing to its anti-inflammatory properties and suppressing the synthesis and secretion of various inflammatory mediators has been found to prolong the period of analgesia upto 48 hrs.Use of Perineural Dexamethsaone has been associated with less analgesic consumption and a lower incidence of post-operative nausea and vomiting |