| CTRI Number |
CTRI/2025/03/081913 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to test a new method of pain relief for patients being operated for esophageal cancer (cancer of foodpipe)
|
|
Scientific Title of Study
|
A prospective interventional pilot study comparing pain relief following an ultrasound-guided Serratus Anterior Plane block in patients undergoing minimally invasive esophagectomy at a tertiary care cancer center, versus retrospectively collected data on standard acute pain management practices |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4633_Protocol Version 1.0 dated 02.10.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bindiya Salunke |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9764924231 |
| Fax |
|
| Email |
bindi02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindiya Salunke |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9764924231 |
| Fax |
|
| Email |
bindi02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yash Goel |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8419894159 |
| Fax |
|
| Email |
yash1416@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesia, Critical Care and Pain, 2nd Floor Main Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra 400012, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E Borges Road Parel, Mumbai Pin 400012 |
| 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 Bindiya Salunke |
Tata Memorial Centre |
Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA |
9764924231
bindi02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMH Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Retrospective data |
Retrospectively collected data on standard acute pain management practices |
| Intervention |
Serratus Anterior Plane (SAP) BLOCK |
SAP block will be given in a bolus dose of 0.4 mL/kg of 0.125% of levo-bupivacaine at the end of the surgery with the use of ultrasonography. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 80 years undergoing MIS esophagectomy |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal.
2. Infection at the site of needle insertion.
3. Previous allergic reactions to local anaesthetic (levobupivacaine) and/or paracetamol and/or diclofenac and/or fentanyl.
4. Contraindications to receive paracetamol (liver enzymes more than 5 times the normal values, Child- Pugh B or C) or diclofenac (serum creatinine more than 1.5 mg percent, single-kidney status, blood loss during the surgery more than 1.5 litres, history of aspirin-induced bronchial asthma)
5. Pregnant Women.
6. Patients whom thoracic epidural is inserted with likely high chances of risk of converting into open thoracotomy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NRS |
NRS- at rest,
NRS- on maximal spirometry effort at 1st 4 hours, 4-12 hours, and 24 hours after reaching the recovery room in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to receive the first rescue analgesic following the MIS esophagectomy surgery.
2. Worst pain score in 24 hours following the surgery.
3. Maximal spirometry effort (average of three attempts) at 0-4 hours, 4-12 hours, and 24 hours following the MIS esophagectomy surgery.
4. The total dose of opioids in terms of ‘morphine equivalent’ (including intraoperative dose) received in the first 24 hours following the MIS esophagectomy surgery.
|
Within 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="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
|
The study will be a prospective interventional study in which we will be giving an injection of Local anaesthetic preferably levo-bupivacaine beneath the servalis anterior muscle more commonly known as the Serratus anterior plane block or the SAP block. The block shall be given in individuals undergoing minimally invasive surgery for esophageal cancer at a tertiary care cancer centre. Post surgery we will be observing the pain relief of the patient and measure the postoperative pain with the help of Numerical Rating scale and patient’s Maximum inspiratory volume at specified time intervals . As a part of the study we shall also be noting down the time when the patient experienced pain for the first time post surgery and the time at which the first rescue analgesic was administered. All patients will be receiving PCM 15mg/kg and diclofenac 1mg/ kg Intraoperatively apart from the block . The data thus obtained shall be compared with the retrospective data maintained on the standard acute main management practices |