Recruiting

Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy

ClinicalTrials.gov IDNCT07738770

PhaseNA

Enrollment72

SponsorDharmais National Cancer Center Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Acute Pain, Post Operative Analgesia, Post Operative Pain, Acute, Breast Cancer, Mastectomy, Regional Anaesthesia, Analgesia Duration, Quality of Recovery (QoR-15)

About this study

Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall. The purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND). Participants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.

Interventions

Procedure: Combined PECS II and Superficial PIP Block — Ultrasound-guided regional nerve block administration consisting of PECS II block (25 mL 0.25% Bupivacaine) and superficial PIP block (10 mL 0.25% Bupivacaine) post-induction of general anesthesia prior to surgical incision.
Procedure: Thoracic paravertebral block (TPVB) — Ultrasound-guided regional nerve block administration consisting of TPVB with 0.25% Bupivacaine (5 mL at T4 level and 5 mL at T6 level) post-induction of general anesthesia prior to surgical incision.

Primary outcomes

Postoperative Quality of Recovery Score (QoR-15) (24 hours postoperatively)
Postoperative Pain Severity (NRS) (Postoperative hours 0, 6, 12, and 24)
Duration of Analgesia (Up to 24 hours postoperatively)

Eligibility information

Inclusion Criteria: 1. Female patients aged 18 to 60 years. 2. Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \[ALND\]). 3. American Society of Anesthesiologists (ASA) physical status I to III. 4. Provided signed written informed consent to participate in the study. Exclusion Criteria: 1. Patient refusal to participate in the study. 2. Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine). 3. Coagulation disorders or coagulopathy. 4. Mastectomy procedure with immediate breast reconstruction. 5. Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl). 6. Cognitive impairment or inability to comprehend the pain assessment scale (NRS). 7. Pregnancy. 8. Active infection at the planned regional block injection site.

Study locations

Dharmais National Cancer Center Hospital, Jakarta, DKI Jakarta 11420 Indonesia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.