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NCT04336917 Clinical Trial

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

Postoperative Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04336917
Other study ID # Breast Cancer-RISS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 31, 2020
Est. completion date March 1, 2021

Study information
Verified date April 2021
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 1, 2021
Est. primary completion date February 5, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Rhomboid Intercostal and Subserratus Plane Block with local anesthetic
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.

Locations
Country Name City State
Turkey Konya Education and Training Hospital Konya

Sponsors (1)
Lead Sponsor Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative opiod consumption Opioid consumptions for both group will be recorded. The first 24 hours postoperatively
Secondary Postoperative pain scores 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. The first 24 hours postoperatively
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