| CTRI Number |
CTRI/2025/02/080811 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Transversus Abdominis Plane Block (TAP) in decreasing pain in patients with Chronic Pancreatitis |
|
Scientific Title of Study
|
Role of Ultrasound-Guided Transversus Abdominis Plane Block (TAP) in decreasing pain in patients with Chronic Pancreatitis: A single arm intervention 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 |
Adithya Kamath |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept. of Surgery,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9922246048 |
| Fax |
|
| Email |
adityaskamath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Raj Kumar N. |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept. of Surgery,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443292979 |
| Fax |
|
| Email |
raj.jipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adithya Kamath |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept. of Surgery,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9922246048 |
| Fax |
|
| Email |
adityaskamath@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Pondicherry, India 605006 |
|
|
Primary Sponsor
|
| Name |
Office of Dean Research |
| Address |
JIPMER, Pondicherry, India 605006 |
| 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 |
| Dr Adithya Kamath |
Pain clinic (OPD 134), SSB 1st floor, JIPMER |
Jipmer Campus Rd, Gorimedu
Pondicherry
PONDICHERRY |
09922246048
adityaskamath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Ultrasound-Guided Transversus Abdominis Plane Block (TAP) |
Patients will receive TAP block via subcostal approach wherein a high-frequency probe will be located in the lower margin of the rib cage between the xiphoid process and the anterosuperior iliac spine at the level of the anterior axillary line & the needle will be inserted above the rectus abdominis muscle and advanced until it is positioned between the anterior edge of the transversus abdominis muscle and posterior rectus sheath. 0.25% Bupivacaine 15 ml + 40 mg of depot methylprednisolone will be injected on each side under USG guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients of Chronic abdominal pain due to chronic pancreatitis within 18- 75 years of age with normal amylase / lipase with no evidence of active inflammation on CT & with VAS score of more than 3. |
|
| ExclusionCriteria |
| Details |
1. Patients with American Society of Anesthesia (ASA) levels IV and V.
2. Pregnancy
3. Patients with Bupivacaine hypersensitivity 
4. Patients requiring surgery for chronic pancreatitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pain relief using Visual Analogue Score (VAS) among patients of Chronic pancreatitis receiving TAP block |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To distinguish the cause of pain into VAPS or AMPS.
2. Cumulative opioid/NSAID requirement before & after the block.
2. Duration of analgesia
3. No. of hospital visits
4. Readmission rates |
2 years |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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)
|
Chronic abdominal pain (pain lasting for <3 months11) seen in CP, is said to be of 2 types1: 1. Visceral Abdominal Pain Syndrome (VAPS) Abdominal Myofascial Pain Syndrome (AMPS) Failure to identify AMPS in patients with CP may lead to frustration for both the patients and the treating surgeon culminating in poor pain control, escalating dose of opioids, mental agony, increased hospital readmission and unreasonable investigations, surgery resulting in increasing hospital expenses. Moreover, the treatment modalities mentioned for visceral pain are ineffective in patients with AMPS. Transversus abdominis plane (TAP) block  is a well-established and a safe procedure for providing post-operative analgesia in surgical patients. To the best of our knowledge, there is only one study in the world & no studies in India that were done to study the effectiveness of TAP block in reducing pain and to distinguish between Visceral Abdominal Pain Syndrome (VAPS) & Abdominal Myofascial Pain Syndrome (AMPS) in patients with Chronic Pancreatitis.
|