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

NCT07738770 | Recruiting

• 1 other identifier: DP.04.03/12.04/122/2026
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

Pectoral Nerve Block; PECS II Block; Parasternal Intercostal Plane Block; Thoracic Paravertebral Block; Mastectomy; Breast Cancer; Postoperative Analgesia; Quality of Recovery

Outcome Measures

Primary Outcomes (3)

• Postoperative Quality of Recovery Score (QoR-15)

  Patient-reported quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, where higher scores indicate better overall recovery quality post-surgery.

  24 hours postoperatively

• Postoperative Pain Severity (NRS)

  Pain severity evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements are recorded separately at rest and during active movement (shoulder joint movement / arm elevation).

  Postoperative hours 0, 6, 12, and 24

• Duration of Analgesia

  Time elapsed from the completion of surgery (extubation/arrival at recovery room) to the patient's first request or activation of the Patient-Controlled Analgesia (PCA) morphine device. Measured in minutes/hours.

  Up to 24 hours postoperatively

Secondary Outcomes (2)

• Regional Block Procedure Execution Time

  Intraoperative (during regional block administration)

• Block-Related Complications

  Intraoperative through 24 hours postoperatively

Study Arms (2)

Combined PECS II and PIP Block Group

EXPERIMENTAL

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.

Procedure: Combined PECS II and Superficial PIP Block

Thoracic Paravertebral Block Group

ACTIVE COMPARATOR

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.

Procedure: Thoracic paravertebral block (TPVB)

Interventions

Combined PECS II and Superficial PIP Block PROCEDURE

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.

Combined PECS II and PIP Block Group

Thoracic paravertebral block (TPVB) PROCEDURE

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.

Thoracic Paravertebral Block Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18 to 60 years.
• Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \[ALND\]).
• American Society of Anesthesiologists (ASA) physical status I to III.
• Provided signed written informed consent to participate in the study.

You may not qualify if:

• Patient refusal to participate in the study.
• Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine).
• Coagulation disorders or coagulopathy.
• Mastectomy procedure with immediate breast reconstruction.
• Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl).
• Cognitive impairment or inability to comprehend the pain assessment scale (NRS).
• Pregnancy.
• Active infection at the planned regional block injection site.

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead

Study Sites (1)

Dharmais National Cancer Center Hospital

Jakarta, DKI Jakarta, 11420, Indonesia

RECRUITING

Related Publications (7)

• Martinez-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 BACKGROUND

• Ledowski 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 BACKGROUND

• Barrington 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 BACKGROUND

• Kleif 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 BACKGROUND

• Kleif 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 BACKGROUND

• Wessels 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 BACKGROUND

• Teng 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.

  PMID: 38448346 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Annisa Annisa, Anesthesiologist

CONTACT

81317235246; annisa157sasa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This trial employs a single-blind masking design in which outcome assessors and clinical staff responsible for postoperative care-including recovery room nurses, ward physicians, and research assistants-are blinded to the treatment allocation. The regional block procedures (combined PECS II + PIP block or Thoracic Paravertebral Block) are performed intraoperatively by designated regional anesthesiologists who are not involved in postoperative outcome assessment or data collection, ensuring an unbiased evaluation of pain scores, quality of recovery, and analgesia duration.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: This study is a prospective, single-blind, randomized controlled trial designed to compare the analgesic efficacy and recovery outcomes of a combined Pectoral Nerve II (PECS II) and Superficial Parasternal Intercostal Plane (PIP) block versus a Thoracic Paravertebral Block (TPVB) in breast cancer patients undergoing mastectomy with or without axillary lymph node dissection. The intervention group receives an ultrasound-guided combination of PECS II and superficial PIP blocks, while the control group receives an ultrasound-guided TPVB. The study focuses on evaluating postoperative pain intensity (Numeric Rating Scale), quality of recovery (QoR-15 questionnaire), duration of analgesia, total postoperative opioid consumption, execution time, and block-related complications over a 24-hour postoperative period.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)