Combined PECS II and PIP blocks vs TPVB for post-mastectomy pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind trial compares two regional analgesia strategies for mastectomy patients. One group receives ultrasound-guided PECS II and superficial parasternal intercostal plane (PIP) blocks before surgery, aiming to cover lateral and anterior chest wall nerves. The control group receives the traditional thoracic paravertebral block. Primary outcomes focus on analgesic efficacy and quality of postoperative recovery, with attention to safety and opioid use. The study is conducted at Dharmais National Cancer Center Hospital in Jakarta, enrolling adult female patients aged 18 to 60 without significant comorbidity or coagulopathy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dharmais National Cancer Center Hospital
  Jakarta, DKI Jakarta, Indonesia Recruiting

Study contacts

• Study coordinator: Annisa Annisa, Anesthesiologist
• Email: annisa157sasa@gmail.com
• Phone: 81317235246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.