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MastectomyNCT06756048

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

A study testing Rhomboid Intercostal Nerve Block in people with Mastectomy and Rhomboid Intercostal Block, run by Koç University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Rhomboid Intercostal Nerve Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Nov 2023to 27 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Koc University Hospital

    Istanbul, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Rhomboid Intercostal Nerve Block
Keywords
mastectomy, rhomboid intercostal block, chronic pain, chronic pain following surgical procedure for cancer, regional anesthesia, bupivacaine
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhomboid Intercostal Nerve BlockProcedure or surgery

    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.

Study groups in NCT06756048
Study groupRoleWhat they receive
Allocated to Intervention (Rhomboid Intercostal Block)ExperimentalGroup 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.
Receives: Procedure: Rhomboid Intercostal Nerve Block
Allocated to No Intervention (Control Group)No interventionGroup 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. 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.

    Measured: from enrollment to end of first postoperative day

  2. 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.

    Measured: from enrollment to end of first postoperative day

  3. 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)

    Measured: from enrollment to end of first postoperative day

  4. 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)

    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.

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

  5. 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)

    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.

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

  6. 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)

    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.

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

  7. 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)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start27 Nov 2023
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06756048
Sponsor's protocol ID
2023.391.IRB1.138
Status last verified
Dec 2024
First submitted
26 Nov 2024
Last updated
1 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD collected through the trial can be shared with third parties upon reasonable request.

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.

    PubMed 19903919

  • 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.

    PubMed 33414157

  • 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.

    PubMed 32611524

  • 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.

    PubMed 35296252

  • 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.

    PubMed 27291611

Questions about this trial

What is this clinical trial studying?

A study testing Rhomboid Intercostal Nerve Block in people with Mastectomy and Rhomboid Intercostal Block, run by Koç University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic pain incidence at postoperative third month (time frame: from enrollment (surgery day) to the end of postoperative third month.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06756048, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.

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