| CTRI Number |
CTRI/2024/12/078279 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two different pain management techniques for control of pain after inguinal surgeries |
|
Scientific Title of Study
|
Ultrasound-guided erector Spinae plane block versus ilioinguinal/iliohypogastric block for postoperative analgesia in patients undergoing inguinal surgeries : A randomised clinical trial |
| 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 Neha Chajgotra |
| Designation |
Senior Resident , Department of Anaesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua, Jammu and Kashmir, India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006903323 |
| Fax |
|
| Email |
Chajgotraneha55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor , Department of Anaesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua,,Jammu and Kashmir,India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor , Department of Anaesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua,,Jammu and Kashmir,India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kathua, district Kathua,Jammu and Kashmir, India pin:184101 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Chajgotra |
| Address |
Senior Resident , Department of Anesthesia and critical care GMC kathua, district Kathua, Jammu and kasmir, India pin 184102 |
| Type of Sponsor |
Other [Self] |
|
|
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 Angral |
Hospital, Government Medical College Kathua |
Department of Anaesthesiology and critical care, GMC Kathua, district Kathua, Jammu and Kashmir, India, pin 184102
Kathua
JAMMU & KASHMIR |
7006047500
rajeshangral73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Medical College Kathua |
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 |
Erector Spinae plane block (ESP) and ilioinguinal / iliohypogastric block (IIIH) |
Usg guided ESP block , interfacial plane block given in paraspinal area in which the needle placement is between the erector Spinae muscle and the thoracic transverse processes of the vertebrae and Usg guided IIIH block given into the fascia plane between the internal oblique and transversus abdominis muscles. |
| Comparator Agent |
Usg guided ESP Block versus Usg guided IIIH Block |
The ESP group will receive 20 ml of total volume of drug containing 18 mL of local anaesthetic Ropivacaine hydrochloride 0.25% + 8 mg of dexamethasone (2ml) and the IIIH group will receive the same composition of the drug . Here two techniques will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients between age group of 18 years to 60years who are undergoing inguinal hernia repair in elective OT
2) ASA class 1 & 2
3) patients who are willing to participate and provide a willing written informed consent |
|
| ExclusionCriteria |
| Details |
1) patients with any chronic medical illness
2) history of any bleeding disorders
3) patients allergic to any of these drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Severity of pain using Numerical Rating Scale (NRS)
2) Time to 1st request of analgesia |
Severity of pain using Numerical Rating Scale (NRS) at 1,2,6,12 and 24 hours after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total number of analgesic doses of opioids and NSAIDS in 24 hours following surgery
2) side effects like nausea, vomiting and shivering
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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
|
This study is a randomised, parallel group, clinical trial comparing the effectiveness of two blocks i.e ultrasound guided Erector Spinae plane block versus ilioinguinal/ iliohypogastric block for postoperative analgesia in patients undergoing inguinal surgeries, as measured by duration of analgesia and pain score in 24 hours following surgery. The primary outcome of the study is to record the severity of pain using Numerical rating scale and time to request of first analgesia i.e the time elapsed between the end of surgery to 1st dose of analgesia. The secondary outcome is to see the total no. of analgesic doses of opioids and NSAIDs in 24 hours following surgery and to see any side effects like nausea, vomiting and shivering occurring after the procedure. |