Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Breast Cancer Surgery

NCT07001657 | Completed

• 1 other identifier: AEAHYE001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Pectoral Nerve Block (PECS II) and the Serratus Posterior Superior Intercostal Plane (SPSIP) Block in patients undergoing breast cancer surgery. The primary outcome is total opioid consumption in the first 24 hours. Secondary outcomes include pain scores (VAS), block performance time, number of needle passes, postoperative recovery quality (QoR-15), time to first analgesic request, and complications (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection).

Conditions

Nerve Block

Keywords

pectoral nerve block; Breast Cancer Surgery; Serratus Posterior Superior Intercostal Plane Block; Postoperative Pain; Patient Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  Total opioid consumption (mg) in the first 24 hours postoperatively, measured using a PCA device.

  the first 24 hours postoperatively

Secondary Outcomes (7)

• Postoperative Visual Analog Scale (VAS) Scores - Static and Dynamic Pain

  1, 3, 6, 12, and 24 hours postoperatively.

• Block performance time

  During the procedure (from ultrasound probe-skin contact until needle withdrawal, assessed preoperatively)

• Number of needle passes

  During the procedure (number of times the needle trajectory was changed without full withdrawal after skin entry, assessed preoperatively)

• Quality of recovery assessed by the QoR-15 scale.

  24 hours postoperatively.

• Time to first analgesic request.

  Within 24 hours postoperatively

Study Arms (2)

SPSIP Block

ACTIVE COMPARATOR

Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.

Procedure: SPSIP Block

PECS II Block

ACTIVE COMPARATOR

Patients in this group will receive an ultrasound-guided PECS II block with 30 mL of 0.25% bupivacaine hydrochloride (20 mL between the pectoralis minor and serratus anterior muscles, and 10 mL between the pectoralis major and minor muscles), 30 minutes before breast cancer surgery.

Procedure: PECS II Block

Interventions

SPSIP Block PROCEDURE

Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.

SPSIP Block

PECS II Block PROCEDURE

Patients in this group will receive an ultrasound-guided PECS II block with 30 mL of 0.25% bupivacaine hydrochloride (20 mL between the pectoralis minor and serratus anterior muscles, and 10 mL between the pectoralis major and minor muscles), 30 minutes before breast cancer surgery.

PECS II Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Body Mass Index (BMI) less than 35 kg/m²
• Unilateral breast cancer surgery

You may not qualify if:

• Patient refusal to participate
• BMI greater than or equal to 35 kg/m²
• ASA physical status IV-V
• Known allergy to any study medications
• Pregnancy or breastfeeding
• Presence of neuromuscular diseases
• Chronic opioid use
• Chronic pain syndromes
• Significant organ failure (e.g., cardiac, hepatic, renal)
• Contraindications to regional nerve blocks
• Bilateral breast surgery

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, 07010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nilgun Kavrut Ozturk, professor

  Antalya Training and Research Hospital

  STUDY DIRECTOR

• Yunus Emre Songur, Resident

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Bahadır Ciftci, Assoc Prof

  Medipol Mega University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 3, 2025
• Study Start: May 25, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 27, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

TU (1)