Breast Cancer Clinical Trials

Find Breast Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Dharmais National Cancer Center Hospital
RECRUITING
Jakarta
Contact Information
Primary
Annisa Annisa, Anesthesiologist
annisa157sasa@gmail.com
81317235246
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 72
Treatments
Experimental: Combined PECS II and PIP Block Group
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.
Active_comparator: Thoracic Paravertebral Block Group
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.
Related Therapeutic Areas
Sponsors
Leads: Dharmais National Cancer Center Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials