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Completed

NCT Number: NCT04297007

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PECS block

Other

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Rhomboid intercostal block

Other

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Primary outcomes

  1. Opioid consumption

    Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

    The primary aim is to compare postoperative opioid consumption

Secondary outcomes

  1. Pain scores (Visual analogue scores-VAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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