A clinical trial to compare pain relief from a nerve block(SPSIPB) versus fentanyl in breast surgery patients

Not yet recruiting

• Conditions: Neoplasm of unspecified behavior of breast, (2) ICD-10 Condition: C00-D49||Neoplasms,

• Registration Number: CTRI/2025/06/088658
• Lead Sponsor: AIIMS New Delhi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-08
• Last Update Posted: 2025-11-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

Patients undergoing unilateral breast surgery 2.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative fentanyl consumption using Patient controlled analgesia (PCA) pump	24hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

All India Institute of Medical Sciences New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences New Delhi

🇮🇳South, DELHI, India

Nishant Patel

Principal investigator

pateldrnishant@gmail.com