| CTRI Number |
CTRI/2024/01/061167 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Other (Specify) [Pain Management] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of nerve block with opiod in relieving pain of patients with acute pancreatitis |
|
Scientific Title of Study
|
Comparision of efficacy of erector spinae plane block versus conventional
pharmacological therapy in successfully alleviating abdominal pain of
patients with pancreatitis in an emergency department: A Randomized
Control 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 Satyendra Meena |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029 Hostel 18, Room 228, Kashyap Hostel, AIIMS, New Delhi-110029 New Delhi DELHI 110029 India |
| Phone |
9643131943 |
| Fax |
|
| Email |
satensmeena@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029
New Delhi DELHI 110029 India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Satyendra Meena |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
AIIMS Emergency Office, Department of Emergency Medicine, AIIMS, New Delhi-110029 Hostel 18, Room 228, Kashyap Hostel, AIIMS, New Delhi-110029 New Delhi DELHI 110029 India |
| Phone |
9643131943 |
| Fax |
|
| Email |
satensmeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine |
| Address |
AIIMS, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Satyendra Meena |
All India Institute of Medical Sciences, New Delhi |
EM-1, Department of Emergency Medicine New Delhi DELHI |
9643131943
satensmeena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Erector Spinae Plane
Block |
Ultrasound guidance Bilateral
erector spinae plane block will
be done on arrival by inserting a nerve block needle with 0.5%
Bupivacaine (calculated amount
by bodyweight) and 4 mg of
Dexamethasone, following that a patient-controlled analgesia pump or PCA pump will be provided which will contain injection Fentanyl as rescue therapy. Patient will be asked to press the PCA pump button whenever he feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 μg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 μg/kg. The total number of demands of rescue analgesia through the PCA will be calculated at 12 hours and 24 hours. |
| Comparator Agent |
Conventional Pharmacological
Therapy |
Patient will be given
injection tramadol 50 mg intravenously bolus thrice a day, along with that a patient-controlled analgesia pump or PCA pump will be provided which will contain injection Fentanyl as rescue therapy. Patient will be asked to press the PCA pump button whenever he feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 μg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 μg/kg. The total number of demands of rescue analgesia through the PCA will be calculated at 12 hours and 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults patients (≥ 18 years of age) who are
already diagnosed as acute or recurrent
acute pancreatitis, presenting to the
emergency department of AIIMS New
Delhi within 7 days of onset of abdominal
pain with DVPRS ≥ 7.
2. Patients willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with hemodynamic instability
2. Patients having one or more organ
dysfunction
3. Patients allergic to drugs
4. Local site infection
5. Spine deformity (both acquired or
congenital)
6. Pregnancy
7. Immunosuppressive state
8. Patients with chronic kidney disease,
chronic liver disease, congestive heart
failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of successful pain relief (more than 50% reduction in pain score by Defense and Veterans Pain Scale(DVPRS) from presentation or DVPRS less than 4 or total
amount of rescue analgesia needed) after six hours of intervention in both ESPB arm
and conventional pharmacological therapy (CPT) arm. |
Primary outcome will be assessed and analysed after six hours of intervention in both ESPB arm
and conventional pharmacological therapy (CPT) arm. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Drugs or procedure related adverse events in both arm |
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department |
Pain score assessment at different time interval (at 1 hour, 6 hours, then every 6
hours up to 24 hours) |
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department |
Pain free interval in both arm: It will be defined as either DVPRS less than 4 or no need of
rescue analgesia. |
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department |
Timing of rescue therapy in both arm and total cumulative dose of fentanyl as rescue
therapy after 12 and 24 hours |
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department |
Patient feedback based on Likert scaling regarding preference of therapy he or she
would opt for in next visit |
Upto 6 hours after intervention or 24 hours if
patient remains in the emergency department |
|
|
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)
|
10/01/2024 |
| 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="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
|
It is a prospective, open label, randomized control trial of parallel-groups to compare the efficacy of erector spinae plane block versus conventional pharmacological therapy in successfully alleviating abdominal pain of patients with pancreatitis in an Emergency Department. Patients of pancreatitis with Abdominal pain will be examined and history will be taken, patients meeting inclusion criteria will be included in the study after taking consent for the study. Patients meeting any one of the exclusion criteria will be excluded from the study. After that, randomization to different study arm patient will be allcocated, randomization will be done by a pre-formed computer generated randomization table and allocation concealement will be done by SNOSE technique. Our primary objective is to assess the efficacy of successful pain relief (more than 50% reduction in pain score by DVPRS from presentation or DVPRS less than 4 in both arm at one hour in both ESPB arm and conventional pharmacological therapy (CPT) arm. Secondary objectives are to assess pain score assessment at different time interval up to 6 hours or up to 24 hours if patient remains in ED, pain free interval in both arm, timing of rescue therapy, drugs or procedure related adverse events in both arm, reasons for failure of therapy in both arm, efficacy of image acquisition and optimization and interpretation by different performers on Likert scale, patient feedback based on Likert scaling regarding preference of therapy he or she would opt for in next visit. |