Effects of Rhomboid Intercostal Block on Postoperative Pain Management and Chronic Pain Incidence in Mastectomies

NCT06756048 | Completed

• 1 other identifier: 2023.391.IRB1.138
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effects of the Rhomboid Intercostal Block (RIB) on postoperative chronic pain prevalence at 3 months (primary outcome) and on acute pain control, total opioid consumption, and the incidence of opioid-related side effects within the first 24 hours (secondary outcomes) in patients undergoing elective mastectomy surgery. The main questions it aims to answer are: Does the application of RIB reduce the prevalence of chronic pain at 3 months postoperatively? Does RIB improve acute pain control and reduce opioid consumption and related side effects in the first 24 hours postoperatively? Researchers will compare patients who receive RIB under general anesthesia to those who do not receive the block to determine its effectiveness in reducing chronic pain prevalence, acute pain scores, and opioid-related outcomes.

Conditions

Mastectomy; Rhomboid Intercostal Block; Chronic Pain Following Surgical Procedure for Cancer

Keywords

mastectomy; rhomboid intercostal block; chronic pain; chronic pain following surgical procedure for cancer; regional anesthesia; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Chronic pain incidence at postoperative third month

  participants will receive a phone call from the researcher at the end of third postoperative period. They will be asked 'are you experiencing any remaining pain' and their responses will be recorded as yes or no. Patients who respond yes will be calculated between groups to find the incidence of chronic pain.

  from enrollment (surgery day) to the end of postoperative third month.

Secondary Outcomes (7)

• total morphine consumption at postoperative 24 hours

  from enrollment to end of first postoperative day

• Postoperative pain levels with Numeric Rating Scale on 1st, 6th, 12th and 24th hours

  from enrollment to end of first postoperative day

• Postoperative nausea and vomiting incidence

  from enrollment to end of first postoperative day

• Limitation on Daily Activities

  from enrollment (surgery day) to the end of postoperative third month.

• Household/Work Activities

  from enrollment (surgery day) to the end of postoperative third month.

Study Arms (2)

Allocated to Intervention (Rhomboid Intercostal Block)

EXPERIMENTAL

Group I: RIB In the first group (Group RIB), patients will receive a Rhomboid Intercostal Block immediately before the induction of general anesthesia. The procedure will be performed with the patient sitting upright and premedicated with anxiolytics. Using ultrasound guidance, a 50 mm block needle will be inserted into the auscultatory triangle (interfascial plane located lateral to the erector spinae muscle, beneath the rhomboid major, and over the intercostal nerves). A total of 20 ml of 0.25% bupivacaine will be administered at this site. If the surgery is unilateral, the RIB will be applied only on the surgical side. For bilateral surgeries, 20 ml of bupivacaine will be administered to each side.

Procedure: Rhomboid Intercostal Nerve Block

Allocated to No Intervention (Control Group)

NO INTERVENTION

Group II: Control Group In the second group (Control Group), patients will undergo the surgical procedure without receiving a Rhomboid Intercostal Block (RIB) or any other regional anesthesia technique. Standard general anesthesia protocols will be followed for these patients, and postoperative pain management will be conducted using systemic analgesics according to the institution's routine practice.

Interventions

Rhomboid Intercostal Nerve Block PROCEDURE

Following standard ASA monitoring, patients were positioned on the surgical table with their backs facing the operator. Skin antisepsis was achieved using povidone. A high-frequency 8-18 MHz linear ultrasound probe was used. After palpating the rhomboid muscles and intercostal spaces at the T6-T7 levels, the medial border of the scapula and the vertebral column were identified. The ultrasound probe was placed horizontally along the medial border of the scapula. Using ultrasound guidance, the ribs, rhomboid muscles, intercostal muscles, and pleura were visualized. Once these anatomical structures were clearly identified, a 50 mm, 22G regional block needle was advanced in-plane from caudal to cranial under ultrasound guidance until the interfascial plane beneath the rhomboid muscles was reached and total of 20 ml of 0.25% bupivacaine (Marcaine® 0.5%, AstraZeneca PLC, London, UK) was injected.

Allocated to Intervention (Rhomboid Intercostal Block)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing one of the following procedures: benign mass excisions, modified radical mastectomies (MRM), simple total mastectomies, nipple-sparing mastectomies, or skin-sparing mastectomies, regardless of additional procedures such as sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), or implant placement.

You may not qualify if:

• Patients undergoing breast augmentation, reduction, or mammoplasty without a mass.
• Patients with a BMI \> 35.
• Emergency cases.
• Patients with bleeding diathesis.
• Known allergy to medications used in the study.
• Patients with asthma.
• Patients diagnosed with chronic kidney failure.
• Pregnant or lactating patients.
• Patients with chronic opioid use.
• Patients with cooperation issues or inadequate communication ability.
• Male patients.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (5)

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 BACKGROUND

• Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7.

  PMID: 33414157 BACKGROUND

• Wang L, Cohen JC, Devasenapathy N, Hong BY, Kheyson S, Lu D, Oparin Y, Kennedy SA, Romerosa B, Arora N, Kwon HY, Jackson K, Prasad M, Jayasekera D, Li A, Guarna G, Natalwalla S, Couban RJ, Reid S, Khan JS, McGillion M, Busse JW. Prevalence and intensity of persistent post-surgical pain following breast cancer surgery: a systematic review and meta-analysis of observational studies. Br J Anaesth. 2020 Sep;125(3):346-357. doi: 10.1016/j.bja.2020.04.088. Epub 2020 Jun 28.

  PMID: 32611524 BACKGROUND

• Chen R, Su S, Shu H. Efficacy and safety of rhomboid intercostal block for analgesia in breast surgery and thoracoscopic surgery: a meta-analysis. BMC Anesthesiol. 2022 Mar 16;22(1):71. doi: 10.1186/s12871-022-01599-4.

  PMID: 35296252 BACKGROUND

• Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

  PMID: 27291611 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yavuz Gürkan, Prof.

  Koc University Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Group RIB: patients in this group will receive rhomboid intercostal block prior to mastectomy (any breast surgery due to a mass) Group Control: patients in this group will not receive any methods of regional anesthesia prior to mastectomy (any breast surgery due to a mass)

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: January 1, 2025
• Study Start: November 27, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD and supporting information will be available to share at the end of enrollment period and upon completion of third month pain data (27 November 2024). The information will be available for two years (until 27 November 2026)
• Access Criteria: The IPD can be received from Dr. Belitsu Salgın (assistant investigator) and Assoc. Prof. Dr. Kamil Darçın (Investigator) upon reasonable request (for a medical research and improvement purpose). all data and statistical test data is available at our records.

Locations

TU (1)