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

Study of the Effects of Rhomboid Intercostal Block on Acute Postoperative Pain Management and Chronic Pain Incidence in Patients Undergoing Oncologic Breast Surgery

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.

Study Overview

• Status: Completed
• Conditions: Mastectomy; Chronic Pain Following Surgical Procedure for Cancer; Rhomboid Intercostal Block
• Intervention / Treatment: Procedure: Rhomboid Intercostal Nerve Block

Detailed Description

Primary Outcome Measures

The primary outcome is the prevalence of chronic pain at 3 months in patients undergoing mastectomy surgery. For patients reporting pain, additional parameters will be assessed, including:

Pain characteristics: location, frequency, intensity, and radiation. Factors that exacerbate or alleviate pain. Impact of pain on quality of life (measured on a 1-5 scale). Types and quantities of analgesics used. Secondary Outcome Measures

Acute Pain Scores:

Pain levels at 1, 6, 12, and 24 hours postoperatively at rest, measured using the Numeric Rating Scale (NRS).

Opioid Consumption and Side Effects:

Total opioid consumption (morphine and tramadol) within the first 24 hours postoperatively.

Incidence of opioid-related side effects, such as nausea, vomiting, and pruritus.

Patient Satisfaction and Sleep Quality:

Satisfaction with the analgesic method (e.g., very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).

Sleep quality ratings (very good, good, moderate, poor, very poor). Willingness to use the same analgesic method again (yes/no).

Chronic Pain Impact on Daily Life (for patients with pain at 3 months):

Degree of limitation in physical activities, household/work tasks, and social life (scored on a scale from 0 = no limitation to 5 = constant limitation).

Impact on psychological well-being (scored on a scale from 0 = no impact to 5 = constant impact).

Study Design and Participants This prospective, randomized, controlled study will be conducted at Koç University Hospital. Participants will include 90 patients undergoing elective mastectomy surgery, aged 18-80 years, and classified as ASA I-III according to the American Society of Anesthesiologists. Written informed consent will be obtained from all participants.

The sample size calculation was based on a 2020 meta-analysis reporting a 59% prevalence of chronic pain at 3 months in patients without any regional block. Using select-statistics.co.uk software, with a two-proportion sample test, a 50% reduction in chronic pain prevalence was considered significant. With a p-value of 0.05 and 80% power, 43 patients per group were required. To increase robustness and account for potential dropouts, 45 patients per group (90 total) will be enrolled.

Randomization and Blinding: Participants will be randomized into two groups using randomizer.org software. RIB will be performed before induction of general anesthesia. No blinding will be performed due to the nature of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Koç University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allocated to Intervention (Rhomboid Intercostal Block); 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; 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.
No Intervention: Allocated to No Intervention (Control Group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption at postoperative 24 hours	patients will be given a patient controlled analgesia device with no infusion, 1 mg morphine bolus and 10 minutes lock time. At 24.hour visit, their total morphine consumption will be recorded and analyzed in between groups for any statistical difference.	from enrollment to end of first postoperative day
Postoperative pain levels with Numeric Rating Scale on 1st, 6th, 12th and 24th hours	Participants NRS pain scores at rest will be recorded for postoperative 1., 6., 12. and 24. hours at visits. They will be asked "on a scale of 0 (no pain) to 10 (worst pain imaginable), how would you rate your level of pain now?" and their answers will be recorded. Numeric Rating Scale is a scale from 0 to 10, 0-1-2-3-4-5-6-7-8-9-10 has 11 possible answers and higher numbers mean worse pain.	from enrollment to end of first postoperative day
Postoperative nausea and vomiting incidence	patients will be monitorized for any opioid related side effects, mainly nausea and vomiting. If any respiratory depression, pruritus occurs it will also be recorded. groups will be compared for opioid related side effect incidence (nausea and vomiting)	from enrollment to end of first postoperative day
Limitation on Daily Activities	At 3 months postoperatively, for patients experiencing pain, secondary outcome measures will include the degree of limitation in physical activities. Patients will be asked "how much your pain limits your daily activities" and will be asked to rate it from 0 to 5. 0 (no limitation); (rarely limits); (sometimes limits); (usually limits); (mostly limits); (constant limitation). Social Life: Assessed on a scale from 0 (no limitation) to 5 (constant limitation). Psychological Well-Being: Impact on psychological well-being will be evaluated on a scale from 0 (no impact) to 5 (constant impact). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.	from enrollment (surgery day) to the end of postoperative third month.
Household/Work Activities	At 3 months postoperatively, for patients experiencing pain, secondary outcome measures will include the degree of limitation in physical activities. Patients will be asked "how much your pain limits your household or work activities" and will be asked to rate it from 0 to 5. 0 (no limitation); (rarely limits); (sometimes limits); (usually limits); (mostly limits); (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.	from enrollment (surgery day) to the end of postoperative third month.
Social Life	At 3 months postoperatively, for patients experiencing pain, secondary outcome measures will include the degree of limitation in social life. Patients will be asked "how much your pain limits your social life" and will be asked to rate it from 0 to 5. 0 (no limitation); (rarely limits); (sometimes limits); (usually limits); (mostly limits); (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.	from enrollment (surgery day) to the end of postoperative third month.
Psychological Well Being	At 3 months postoperatively, for patients experiencing pain, secondary outcome measures will include the degree of limitation in social life. Patients will be asked "how much your pain limits your psychological well being" and will be asked to rate it from 0 to 5. 0 (no limitation); (rarely limits); (sometimes limits); (usually limits); (mostly limits); (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.	from enrollment (surgery day) to the end of postoperative third month.

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Study Director: Yavuz Gürkan, Prof., Koc University Medical School

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
• 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.
• 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.
• 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.
• 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. Erratum In: BMC Anesthesiol. 2022 Apr 8;22(1):101. doi: 10.1186/s12871-022-01643-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; bupivacaine; regional anesthesia; mastectomy; rhomboid intercostal block; chronic pain following surgical procedure for cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2023.391.IRB1.138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected through the trial can be shared with third parties upon reasonable request.
• IPD Sharing 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)
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No