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Completed

NCT Number: NCT04336917

Ultrasound Guided Rhomboid Intercostal and Subserratus Plane Block in Breast Cancer Surgeries

Postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. Interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. We aimed to investigate the efficacy of Rhomboid intercostal and subserratus plane block (RISS) for postoperative analgesia in patients undergoing breast cancer surgery.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

About this study

This prospective randomized controlled trial will be carried out on female patients who scheduled for breast cancer surgery. Our hypotesis is that this new interfascial plane block technique will able to provide postoperative analgesia in breast cancer surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients aged 18-85 years and ASA physiological score I-III who undergone breast cancer surgery

Exclusion criteria

  • Patients refused to participate.
  • Patients with known or suspected allergy to the used medication.
  • Patients with psychiatric-neurological disorders that may affect pain perception,
  • Patients regularly taking antipsychotics and antidepressants.
  • Patients with potential risk of coagulopathy.
  • Uncooperative patients.

Treatment and study plan

Rhomboid Intercostal and Subserratus Plane Block with local anesthetic

Drug

Local anesthetic will be injected in the tissue planes between the rhomboid and the intercostal muscles and the serratus anterior and external intercostal muscles with ultrasound guidence.

Other names: 40 mL of bupivacaine/lidocaine mixture

Primary outcomes

  1. Postoperative opiod consumption

    Time frame: The first 24 hours postoperatively

    Opioid consumptions for both group will be recorded.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: The first 24 hours postoperatively

    Postoperative pain will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain).The NRS will be recorded in postoperative unit and in ward at first hour and at 2th, 6th, 12th and 24 th hour.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2020
Registry last updated
Apr 20, 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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