Acute PainPECS-TPVBNCT07738770
Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy
A study testing Combined PECS II and Superficial PIP Block and Thoracic paravertebral block (TPVB) in people with Acute Pain and Post Operative Analgesia, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Acute Pain, Post Operative Analgesia, Post Operative Pain, Acute
- What is being tested?
- Combined PECS II and Superficial PIP Block and Thoracic paravertebral block (TPVB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Jun 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Dharmais National Cancer Center Hospital
Jakarta, DKI Jakarta, 11420
Annisa Annisa, Anesthesiologist, 81317235246 ext. +62, annisa157sasa@gmail.com
About this study
Official title: 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
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.
Read the detailed description
Breast cancer surgery, particularly mastectomy with or without axillary lymph node dissection (ALND), is associated with significant acute postoperative pain. Inadequate pain control in the immediate postoperative period can prolong hospital stay, delay functional recovery, and increase the risk of persistent post-mastectomy pain syndrome. While Thoracic Paravertebral Block (TPVB) has long been considered a gold standard for unilateral thoracic surgery analgesia, its technical difficulty and risk of serious complications such as pneumothorax and systemic toxicity prompt the search for safer alternatives.
The PECS II block targets the lateral and medial pectoral nerves, intercostobrachial nerve, and lateral cutaneous branches of intercostal nerves T2-T6. However, it may not consistently cover the anterior cutaneous branches near the sternum. Combining the PECS II block with a Superficial Parasternal Intercostal Plane (PIP) block aims to provide complete coverage of both the lateral and anterior thoracic wall, potentially offering comparable or superior analgesia to TPVB with a lower complication profile.
In this single-blind randomized controlled trial conducted at Dharmais Cancer Hospital, eligible female patients scheduled for mastectomy are randomized into two parallel groups:
- Intervention Group: Receives an ultrasound-guided combination of PECS II block (25 mL 0.25% Bupivacaine) and Superficial PIP block (10 mL 0.25% Bupivacaine) prior to surgical incision.
- Control Group: Receives an ultrasound-guided Thoracic Paravertebral Block at T4 and T6 levels (10 mL total of 0.25% Bupivacaine).
Standardized general anesthesia and intraoperative monitoring (including hemodynamics and qNOX index for depth of analgesia) are maintained for all subjects. Postoperatively, patients receive standard oral paracetamol and IV ketorolac, supplemented with IV Morphine via a Patient-Controlled Analgesia (PCA) device.
Study endpoints include Numeric Rating Scale (NRS) pain scores evaluated at rest and movement at 0, 6, 12, and 24 hours post-surgery; quality of recovery measured via the QoR-15 questionnaire at 24 hours; time to first PCA activation (duration of analgesia); total 24-hour morphine consumption; and monitoring for complications including local anesthetic systemic toxicity (LAST), hematoma, and pneumothorax.
- Conditions
- Acute Pain, Post Operative Analgesia, Post Operative Pain, Acute, Breast Cancer, Mastectomy, Regional Anaesthesia
- Being tested
- Combined PECS II and Superficial PIP Block, Thoracic paravertebral block (TPVB)
- Keywords
- Pectoral Nerve Block, PECS II Block, Parasternal Intercostal Plane Block, Thoracic Paravertebral Block, Mastectomy, Breast Cancer, Postoperative Analgesia, Quality of Recovery
- Medical subject headings
- Acute Pain, Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined PECS II and Superficial PIP BlockProcedure or surgery
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.
Thoracic paravertebral block (TPVB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Thoracic paravertebral block (TPVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Up to 24 hours postoperatively
Secondary outcomes (2)
Regional Block Procedure Execution Time
Total time taken to perform the assigned regional block, measured in seconds/minutes from initial patient positioning and USG scanning until the completion of local anesthetic injection.
Measured: Intraoperative (during regional block administration)
Block-Related Complications
Number of participants experiencing procedure- or drug-related complications, including Local Anesthetic Systemic Toxicity (LAST), injection site hematoma, injection site infection, and pneumothorax.
Measured: Intraoperative through 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start29 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dharmais National Cancer Center Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Annisa, Dharmais National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738770
- Sponsor's protocol ID
- DP.04.03/12.04/122/2026
- Acronym
- PECS-TPVB
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect patient confidentiality and privacy. Aggregated study results and anonymized data may be made available upon reasonable request to the corresponding author, subject to institutional ethics committee approval and data sharing agreements.
Publications
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.
PubMed 35172074Ledowski 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.
PubMed 31047645Barrington 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.
PubMed 31490251Kleif 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.
PubMed 29605019Kleif 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.
PubMed 29397134Wessels 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.
PubMed 35190342Teng 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.
PubMed 38448346