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

Phase 4

Completed

• Conditions: Breast Cancer Surgery; Postoperative Analgesia
• Interventions: Drug: Rhomboid Intercostal and Subserratus Plane Block with local anesthetic

• Registration Number: NCT04336917
• Lead Sponsor: Konya Meram State Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-04
• Study First Posted: 2020-04-07
• Study Start: 2020-08-31
• Primary Completion: 2021-02-05
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-18
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Rhomboid Intercostal and Subserratus Plane Block	Rhomboid Intercostal and Subserratus Plane Block with local anesthetic	In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve Rhomboid Intercostal and Subserratus Plane Block under ultrasound guidence at the end of the surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative opiod consumption	The first 24 hours postoperatively	Opioid consumptions for both group will be recorded.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	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.

Trial Locations

Locations (1)

Konya Education and Training Hospital; 🇹🇷 Konya, Turkey