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

NCT04336917 | Completed Phase 4

• 1 other identifier: Breast Cancer-RISS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Surgery; Postoperative Analgesia

Keywords

Rhomboid intercostal and subserratus plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative opiod consumption

  Opioid consumptions for both group will be recorded.

  The first 24 hours postoperatively

Secondary Outcomes (1)

• Postoperative pain scores

  The first 24 hours postoperatively

Study Arms (2)

Group Rhomboid Intercostal and Subserratus Plane Block

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

Routine standard perioperative and postoperative analgesic protocol will be given.

Interventions

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.

Also known as: 40 mL of bupivacaine/lidocaine mixture

Group Rhomboid Intercostal and Subserratus Plane Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthetics, Local; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Betul Kozanhan, M.D.

  SBÜ Konya EAH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Model Details: Prospective study

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 7, 2020
• Study Start: August 31, 2020
• Primary Completion: February 5, 2021
• Study Completion: March 1, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

TU (1)