| CTRI Number |
CTRI/2025/08/092617 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Regional Block in Emergency Medicine Department] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A pilot study comparing a nerve block (ESPB) and Fentanyl for treating patients with severe back pain in the Emergency Department. |
|
Scientific Title of Study
|
Efficacy of the Erector Spinae Plane Block (ESPB) versus Fentanyl for alleviating pain in patients with acute severe backache in the Emergency Department: a comparative parallel-group two-arm open label pilot 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 Abhisek Nayak |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department Of Emergency Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
6370238947 |
| Fax |
|
| Email |
abhisekn89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room - 129, JPNATC, Department Of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room - 129, JPNATC, Department Of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department Of Emergency Medicine, All India Institute of Medical Sciences, Ansari Nagar, 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 Abhisek Nayak |
AIIMS, New Delhi |
Department Of Emergency Medicine and Trauma Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029
South
DELHI |
6370238947
abhisekn89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block (ESPB) |
The patient will be positioned in their comfortable posture (sitting, recumbent, lateral rotation). The site for block will depend upon patient’s presentation. For patients with localized pain and tenderness, block will be given at that site. But for patients with diffuse pain with or without tenderness, block will be given bilaterally. The target spinous process is the vertebrae located at the site of maximum pain or tenderness for providing adequate analgesia. Target process will be identified by counting the vertebrae from C7 spine, which is the most prominent vertebrae. LA will be injected at the site of maximum pain or tenderness. The ultrasound transducer will be placed in a longitudinal parasagittal fashion, 3 cm lateral to the target spinous processes, which allows for the visualization of adjacent transverse processes (TP) in an in-plane approach. After the identification of correct TP, that is the transverse process of the vertebrae pertaining to the site of maximum pain or tenderness, a subcutaneous bleb (26 gauze needle) will be formed by infiltrating local anaesthesia for portal of entry of the needle. An 18-gauge echogenic needle will be inserted using an in-plane technique, and cranio-caudad approach will be used to contact the TP with the tip of the needle deep to the fascial plane of the erector spinae muscle. Needle placement will be confirmed by hydro-dissection of the muscle planes on injecting 10 ml of normal saline. Then, calculated amount of 2% lidocaine of 4.5mg/kg, 0.25% Bupivacaine of 1mg/kg and 4mg Dexamethasone will be injected into the fascial plane deep to erector spinae muscle. This solution will be diluted with normal saline so that the volume injected on each site will be at least 20ml. After the intervention, 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/she feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 mcg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 mcg/kg. This meant that the pump will deliver fentanyl only after 15 minutes of the last dose even if a patient presses the button repeatedly. |
| Comparator Agent |
Fentanyl |
In Fentanyl arm patient will be given injection Fentanyl 1 mcg/kg IV stat. After the intervention, 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/she feels pain, a predetermined amount of fentanyl will be delivered. The demand dose for fentanyl will be 0.3 mcg/kg with a lockout interval of 15 minutes and a 1-hour limit of 1.2 mcg/kg. This meant that the pump will deliver fentanyl only after 15 minutes of the last dose even if a patient presses the button repeatedly. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years or older
2. Acute severe lumbar back pain
3. DVPRS score of 7 or more
|
|
| ExclusionCriteria |
| Details |
1. Symptoms of cauda equina syndrome
2. Progressive neurologic symptoms
3. Abdominal Aorta Aneurysm
4. Vertebral fracture
5. Evidence of skin/soft tissue infection at the block site
6. Spine deformity (both acquired or congenital)
7. Known Bleeding Disorder
8. Unwillingness to participate
9. Allergy to any of the research medications
10. Pregnancy
11. Patients of Chronic liver disease, Chronic kidney Disease, Congestive heart failure
12. Immunocompromised patients
13. Hemodynamically unstable patients
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of successful pain relief after six hours of intervention in both ESPB arm and Fentanyl arm |
30 minutes, 1 hour, 2 hours, 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study safety of ESPB in comparison to Fentanyl at 6 hours |
6 hours |
| To evaluate patient satisfaction among patient groups receiving ESPB versus Fentanyl in terms of reduction of pain in Likert scale (from 0: ‘‘Very unsatisfied¨ to 5: ‘‘very satisfied¨) |
6 hours |
| To assess the amount of rescue analgesic medications required at 6 hours of intervention |
6 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="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
|
This study is designed as a comparative parallel group, two arm, open label, pilot randomized control trial to evaluate the efficacy of the Erector Spinae Plane Block versus Fentanyl in managing acute severe backache in patients presenting to the Emergency Department. Eligible participants include individuals aged 18 years or older who present with acute severe lumbar back pain, whether due to mechanical causes, malignancy related pain or trauma after excluding vertebral fractures. Each patient will undergo a thorough history taking and clinical examination. Those who are hemodynamically stable, have no known allergies to the study drugs and score of 7 or more on Defence and Veteran Pain Rating Scale will be enrolled, provided they meet all the inclusion criteria and no exclusion criteria apply. Randomization will be conducted using preformed, computer generated sequences employing a mixed block randomization method. To maintain allocation concealment, the generated sequences will be sealed in opaque envelopes. The primary objective is to evaluate the effectiveness of pain relief achieved six hours post intervention in both the ESPB and Fentanyl arms. The secondary objectives include assessing the safety profile, patient satisfaction and the quantity of rescue analgesic medications required within six hours post intervention, comparing outcomes between the intervention and control groups. |