Clinical trial · Interventional
Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy
Analgesic Efficacy Comparison of Combined PECS II and Superficial Parasternal Intercostal Plane (PIP) Block Versus Thoracic Paravertebral Block Post-Mastectomy: An Assessment of Pain Severity, Analgesia Duration, and Recovery Quality
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Analgesia Duration | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
| Post Operative Analgesia | — | UNRESOLVED | — |
| Post Operative Pain, Acute | — | UNRESOLVED | — |
| Quality of Recovery (QoR-15) | — | UNRESOLVED | — |
| Regional Anaesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined PECS II and Superficial PIP Block | Procedure | — | UNRESOLVED |
| Thoracic paravertebral block (TPVB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combined PECS II and PIP Block Group
- description
- Participants receive an ultrasound-guided combination of PECS II block and superficial Parasternal Intercostal Plane (PIP) block following general anesthesia induction. The PECS II block includes 15 mL of 0.25% Bupivacaine injected into the pecto-serratus plane and 10 mL of 0.25% Bupivacaine into the interpectoral plane at the T3-T4 level. The superficial PIP block includes 10 mL of 0.25% Bupivacaine injected between the pectoralis major and external intercostal muscles at the T4-T5 level. Total local anesthetic volume is 35 mL.
- interventionNames
- Procedure: Combined PECS II and Superficial PIP Block
- type
- ACTIVE_COMPARATOR
- label
- Thoracic Paravertebral Block Group
- description
- Participants receive an ultrasound-guided Thoracic Paravertebral Block (TPVB) in the lateral decubitus position following general anesthesia induction. Injection of 5 mL 0.25% Bupivacaine per level is administered into the paravertebral space at thoracic levels T4 and T6. Total local anesthetic volume is 10 mL.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDMartinez-Vazquez P, Jensen EW. Different perspectives for monitoring nociception during general anesthesia. Korean J Anesthesiol. 2022 Apr;75(2):112-123. doi: 10.4097/kja.22002. Epub 2022 Feb 17. PMID 35172074
- BACKGROUNDLedowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30. PMID 31047645
- BACKGROUNDBarrington MJ, Seah GJ, Gotmaker R, Lim D, Byrne K. Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration. Anesth Analg. 2020 Jun;130(6):1559-1567. doi: 10.1213/ANE.0000000000004371. PMID 31490251
- BACKGROUNDKleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21. PMID 29605019
- BACKGROUNDKleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PMID 29397134
- BACKGROUNDWessels E, Perrie H, Scribante J, Jooma Z. Quality of recovery in the perioperative setting: A narrative review. J Clin Anesth. 2022 Jun;78:110685. doi: 10.1016/j.jclinane.2022.110685. Epub 2022 Feb 18. PMID 35190342
- BACKGROUNDTeng WN, Lin YS, Sung CS, Tseng LM, Chang WK, Ting CK. Analgesia-nociception index accurately predicts inadequate pectoralis muscle fascia block (PECS) in patients undergoing breast surgery: A prospective observational study. J Formos Med Assoc. 2025 Jan;124(1):38-43. doi: 10.1016/j.jfma.2024.02.019. Epub 2024 Mar 5.