Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy 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 challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited.

This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18 to 65 years.

Scheduled for elective modified radical mastectomy under general anesthesia.

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

Body mass index (BMI) <35 kg/m².

Disqualifiers

Known allergy or hypersensitivity to local anesthetics.

Coagulation disorders or bleeding diathesis.

Infection or inflammation at the planned block site.

ASA physical status IV or higher.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

    Procedure/Surgery

    An ultrasound-guided serratus posterior superior intercostal plane block will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles.

  • Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

    Procedure/Surgery

    Ultrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: SPSIP BlockExperimental treatment 1 intervention
Group B: SAP BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity

Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.

Time frame
24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)

Secondary outcomes

1

Intraoperative remifentanil consumption

Total intraoperative remifentanil consumption will be recorded in micrograms.

Time frame
During surgery
2

Postoperative tramadol consumption

Total tramadol consumption delivered by patient-controlled analgesia (PCA) during the first 24 postoperative hours.

Time frame
24 hours after surgery
3

Postoperative nausea and vomiting

Postoperative nausea and vomiting will be evaluated using a 5-point PONV score.

Time frame
24 hours after surgery
4

Quality of recovery

Quality of recovery will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire.

Time frame
24 hours after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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