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

April 18, 2021 updated by: Betul Kozanhan, Konya Meram State Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Konya Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Rhomboid Intercostal and Subserratus Plane Block
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.
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.
Other Names:
  • 40 mL of bupivacaine/lidocaine mixture
No Intervention: Control Group
Routine standard perioperative and postoperative analgesic protocol will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opiod consumption
Time Frame: The first 24 hours postoperatively
Opioid consumptions for both group will be recorded.
The first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Investigators

  • Principal Investigator: Betul Kozanhan, M.D., SBÜ Konya EAH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

February 5, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 4, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast Cancer-RISS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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