| CTRI Number |
CTRI/2024/01/061879 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comprehensive Study on Pain Relief Methods Comparing Erector Spinae Plane Block and Paravertebral Block in subcostal incision abdominal surgery |
|
Scientific Title of Study
|
Comparison of Analgesic efficacy of Erector Spinae plane block with Paravertebral block in adult patient undergoing subcostal incision abdominal surgery: a randomized controlled 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 |
PRINCE KUMAR |
| Designation |
ACADEMIC JUNIOR RESIDENT |
| Affiliation |
AIIMS PATNA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA
PHULWARISHARIF, PATNA, BIHAR
Patna
BIHAR
801507
India |
| Phone |
7759835577 |
| Fax |
|
| Email |
whitecoatno.60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
POONAM KUMARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA, PHULWARISHARIF
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonamk@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
POONAM KUMARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS PATNA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA, PHULWARISHARIF
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonamk@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology AIIMS Patna, Bihar, India - 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of anaesthesiology B Block OT Complex , 5th floor IPD building, AIIMS Patna |
| 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 |
| Prince kumar |
All India Institute of Medical Sciences, Patna |
DEPARTMENT OF ANAESTHESIOLOGY, 5TH FLOOR OT COMPLEX,IPD BUILDING Patna BIHAR
Patna
BIHAR |
7759835577
whitecoatno.60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
20ml of 0.25% bupivacaine |
| Intervention |
Paravertebral plane block |
20 ml 0.25% bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 yrs to 75 yrs ASA I and II patients for scheduled to undergo elective subcostal incision abdominal surgery |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 yrs and more than 75 yrs
ASA III and IV patients
Patients refusing for study
Local site infection or lesions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative 24 hour opioid consumption |
To compare the post operative 24 hour opioid consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time of first rescue analgesic administration |
From the time of administration of block to the first need of use of analgesic administration |
| To compare intra operative opioid consumption |
From the time of administration of block to the end of the surgery |
| To measure the average pain NRS score at 24 hour post operative period. |
30 minutes, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
24/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Upper abdominal surgeries often involve extensive tissue manipulation and surgical incisions, which can result in significant postoperative pain. Adequate analgesia is essential to ensure patient comfort and promote a smoother recovery process. Effective pain management plays a crucial role in enhanced recovery after surgery (ERAS) protocols. By providing optimal analgesia, patients experience reduced pain and discomfort, enabling them to mobilize earlier, resume normal activities, and achieve faster recovery. Inadequate pain control can lead to decreased respiratory function, shallow breathing, and impaired lung expansion. This can potentially increase the risk of postoperative complications, such as atelectasis and pneumonia. Optimal analgesia helps maintain respiratory function, reducing the likelihood of such complications. Adequate pain relief promotes patient satisfaction and overall well-being. Patients experiencing well-controlled pain are more likely to have a positive perception of their surgical experience, resulting in higher patient satisfaction scores. Achieving effective pain control requires a multimodal approach that combines different analgesic techniques and medications. Thoracic paravertebral block (TPVB) has been successfully used as anaesthesia for liver and kidney tumor ablation surgery. Different analgesia techniques, including local anaesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative pain. Thoracic paravertebral block (TPVB) is an effective technique in controlling pain after lower thoracic and upper abdominal surgeries. The erector spinae block has demonstrated efficacy in various surgical procedures, including thoracic surgery, breast surgery, and abdominal surgery. |