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

NCT ID: NCT04336917

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-03-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer Surgery Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rhomboid Intercostal and Subserratus Plane Block with local anesthetic

Intervention Type 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.

Control Group

Routine standard perioperative and postoperative analgesic protocol will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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40 mL of bupivacaine/lidocaine mixture

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Betul Kozanhan

Ass.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betul Kozanhan, M.D.

Role: PRINCIPAL_INVESTIGATOR

SBÜ Konya EAH

Locations

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Konya Education and Training Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Breast Cancer-RISS

Identifier Type: -

Identifier Source: org_study_id

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