| CTRI Number |
CTRI/2025/06/088658 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare pain relief from a nerve block(SPSIPB) versus fentanyl in breast surgery patients |
|
Scientific Title of Study
|
Analgesic Efficacy of Serratus posterior superior intercostal plane block (SPSIPB) in breast surgeries: A randomised 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 |
Nishant Patel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5008,Anaesthesiology office,Department of Anaesthesiology,Pain Medicine and Critical Care,5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishant Patel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5008,Anaesthesiology office,Department of Anaesthesiology,Pain Medicine and Critical Care,5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil D |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5011,Anaesthesiology office,Department of Anaesthesiology,Pain Medicine and Critical Care,5th floor, Academic block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8073672116 |
| Fax |
|
| Email |
dnikhil731@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology,Pain Medicine and Critical Care,AIIMS New Delhi,Ansari Nagar 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 |
| Nishant Patel |
All India Institute of Medical Sciences New Delhi |
Surgical block operation theatres and postoperative ward, All India Institute of Medical sciences, New Delhi
South
DELHI |
850195582
pateldrnishant@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: D493||Neoplasm of unspecified behavior of breast, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General anaesthesia with Serratus posterior superior intercostal plane block
(SPSIPB) using 30 ml of 0.25% Ropivacaine+ 4mg Dexamethasone |
Serratus posterior superior intercostal plane block (SPSIPB) provides analgesia to posteroanterolateral chest wall including axillary area. This will be administered 30 mins before general anaesthesia for perioperative analgesia. |
| Comparator Agent |
General anaesthesia with skin infiltration using 5ml of 0,125% Ropvacaine at T3 vertebral level |
General anaesthesia without any block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing unilateral breast surgery
2. aSA I-II |
|
| ExclusionCriteria |
| Details |
1. Unwilling to participate
2. Local or systemic infection
3. Known allergy to study drugs
4. Known coagulopathy
5. Patients with BMI more than or equal to 35
6. Patients with chest wall deformity
7. Cognitive impairment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative fentanyl consumption using Patient controlled analgesia (PCA) pump |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative quality of recovery using QoR-15 scale |
Before the surgery and 24 hours postoperatively |
| Pain assessed using Static and dynamic(on ipsilateral abduction of arm) NRS score |
0,2,4,6,12,24 hours after surgery |
| Incidence of postoperative nausea and vomiting(PONV) |
24 hrs |
| Time of first rescue analgesia given |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/08/2025 |
| 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) |
Open to Recruitment |
|
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
|
Effective postoperative analgesia management using regional anaesthesia technique is found to be standard of care in improving quality of care following breast surgery. Regional anesthesia is transforming postoperative care in breast surgery–providing effective pain relief while significantly reducing opioid use and its associated side effects like nausea and vomiting. Traditionally, thoracic epidural and paravertebral blocks were used for postoperative analgesia following breast surgery However,due to their invasive nature and higher risk of complications, anesthesiologists now increasingly favor ultrasound guided interfascial plane blocks as safer and more precise alternatives. Recently, a novel block called serratus posterior superior intercostal plane block (SPSIP) was described. Preliminary case reports suggest that it offers effective pain relief, with reduced opioid requirements in procedures such as mastectomies with axillary lymph node dissection.Based on the current evidence and clinical observations, the SPSIP block appears to be a promising technique for reducing perioperative and postoperative opioid consumption in patients undergoing breast surgery. This study aims to compare the efficacy of SPSIP block in the context of breast surgeries, focusing on their impact on postoperative pain management, opioid consumption, and patient outcomes. By comparing this to a control group, we aim to assess this novel interfascial plane block technique in breast surgeries.
|