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Completed

NCT Number: NCT04752150

ESPB and RIB 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 erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Forero. 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 pain scores (VAS), and the secondary aim is to evaluate postoperative opioid consumption, adverse effects related with opioids (allergic reaction, nausea, vomiting).

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Key information

Age range

18 year–65 year

Sex eligibility

Female

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. 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 US-guided erector spina plane block (ESPB) is defined by Forero et al. ESPB provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.

The aim of this study is to evaluate the efficacy of the US-guided ESPB and RIB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative pain scores (VAS), and the secondary aim is to evaluate opioid consumption, 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

  • receiving anticoagulant treatment,
  • known study drugs allergy,
  • opioid addiction
  • infection of the skin at the site of the block,
  • pregnancy or lactation,

Treatment and study plan

Analgesia management; group ESPB and RIB

Other

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. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Primary 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.

    The primary aim is to compare VAS. 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

Secondary outcomes

  1. Opioid consumption

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

    The secondary aim is to compare postoperative opioid consumption

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Jan 21, 2022

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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