The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties.

This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction.

The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged between 18 and 65 years

American Society of Anesthesiologists (ASA) physical status I-III

Body Mass Index (BMI) <35 kg/m²

Normal International Normalized Ratio (INR) value and platelet count

Disqualifiers

Bleeding diathesis

Allergy to local anesthetic agents

Suspected infection or inflammation at the planned block site

ASA physical status IV or higher

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serratus Posterior Superior Intercostal Plane Block

    Procedure/Surgery

    Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

  • Serratus anterior plane block (SAP)

    Procedure/Surgery

    Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Serratus Posterior Superior Intercostal Plane (SPSIP) blockExperimental treatment 1 intervention
Group B: Serratus Anterior Plane (SAP) blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity assessed by Visual Analog Scale (VAS)

Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain." VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery. Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.

Time frame
At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery

Secondary outcomes

1

Intraoperative remifentanil consumption

Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.

Time frame
During surgery
2

Total postoperative tramadol consumption within 24 hours

Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.

Time frame
First 24 hours after surgery
3

Postoperative nausea and vomiting (PONV) scores

Postoperative nausea and vomiting will be assessed using a standardized Postoperative Nausea and Vomiting (PONV) severity scale ranging from 0 to 3, where 0 indicates no nausea or vomiting, 1 indicates mild nausea, 2 indicates severe nausea or a single episode of vomiting, and 3 indicates multiple episodes of vomiting. PONV scores will be recorded and compared between groups during the postoperative period. Higher scores indicate more severe postoperative nausea and vomiting and therefore worse clinical outcomes.

Time frame
First 24 hours after surgery

Other outcomes

Sponsors and contacts

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