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Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Not Applicable
Completed
Conditions
Breast Diseases
Breast Neoplasms
Breast Cancer
Breast Fibroadenoma
Registration Number
NCT04297007
Lead Sponsor
Medipol University
Brief Summary

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The primary aim of the study is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Detailed Description

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for mastectomy and axillary dissection surgery under general anesthesia
Exclusion Criteria
  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Opioid consumptionChanges from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

The primary aim is to compare postoperative opioid consumption

Secondary Outcome Measures
NameTimeMethod
Pain scores (Visual analogue scores-VAS)Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours.

Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Trial Locations

Locations (1)

Istanbul Medipol University Hospital

🇹🇷

Istanbul, Bagcilar, Turkey

Istanbul Medipol University Hospital
🇹🇷Istanbul, Bagcilar, Turkey

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