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

Not Applicable

Completed

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

• Registration Number: NCT06756048
• Lead Sponsor: Koç University

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.

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 Timeline

• Study Start: 2023-11-27
• Study First Submitted: 2024-11-26
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chronic pain incidence at postoperative third month	from enrollment (surgery day) to the end of 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.

Secondary Outcome Measures

Name	Time	Method
total morphine consumption at postoperative 24 hours	from enrollment to end of first postoperative day	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.
Postoperative pain levels with Numeric Rating Scale on 1st, 6th, 12th and 24th hours	from enrollment to end of first postoperative day	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.
Postoperative nausea and vomiting incidence	from enrollment to end of first postoperative day	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)
Limitation on Daily Activities	from enrollment (surgery day) to the end of postoperative third month.	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); 1. (rarely limits); 2. (sometimes limits); 3. (usually limits); 4. (mostly limits); 5. (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.
Household/Work Activities	from enrollment (surgery day) to the end of postoperative third month.	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); 1. (rarely limits); 2. (sometimes limits); 3. (usually limits); 4. (mostly limits); 5. (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.
Social Life	from enrollment (surgery day) to the end of postoperative third month.	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); 1. (rarely limits); 2. (sometimes limits); 3. (usually limits); 4. (mostly limits); 5. (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.
Psychological Well Being	from enrollment (surgery day) to the end of postoperative third month.	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); 1. (rarely limits); 2. (sometimes limits); 3. (usually limits); 4. (mostly limits); 5. (constant limitation). These measures aim to evaluate the broader effects of pain on patients' quality of life and functional outcomes.

Trial Locations

Locations (1)

Koc University Hospital; 🇹🇷 Istanbul, Turkey