Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy

September 18, 2025 updated by: Başak Altıparmak, Muğla Sıtkı Koçman University

The Effect of Single Shot Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy Surgery

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute pain following breast surgeries. However, it's effect on chronic pain has not been evaluated yet. The primary hypothesis of the study is that the incidence of chronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 6th month. An other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group than control group at the postoperative 3rd and the 6th months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is designed as a prospective, double-blinded, randomize controlled study. The patients who will undergo mastectomy surgery with or without axillary dissection will be included in the study. Anesthesia will be inducted with intravenous (iv) thiopental 5 mg/kg, fentanyl 2 mcg/kg and rocuronium bromide 0.6 mg/kg. Following intubation, patients will be allocated into two groups according to a randomization table created by a professional statistician. In the study group, patients will receive a single shot Rhomboid Intercostal Block (RIB) with 30 milliliters of %0.25 bupivacaine and in the control group no block procedure will be performed. All patients will receive a standard analgesia protocol which will include an intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg 15 minutes prior to the end of the surgery. Postoperative pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). Pain scores of the patients will be recorded at the postoperative 15. and 30. min in the recovery room and if the NRS score is 4 or more, iv fentanyl 1 mcg/kg will be applied. At the surgical ward, pain scores will be evaluated at the postoperative 1st, 2nd, 6th, 12th and 24th hours and if the NRS score is 4 or more, iv tramadol 50 mg will be applied as rescue analgesia. Opioid consumptions of the patients will be recorded at the postoperative 24th hour. At the postoperative 3. and 6. months, a pain doctor will evaluate all patients by using Brief Pain Inventory Short Form (BPI-SF) and Douleur Neuropathique 4 (DN4) questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • MENTEŞE
      • Muğla, MENTEŞE, Turkey (Türkiye), 48000
        • Muğla Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I-II patients
  • Female
  • Ages between 18-65
  • Patients who will receive breast cancer surgery under general anesthesia

Exclusion Criteria:

  • Alcohol or substance or chronic opioid consumption story
  • Any pain killers intake in the last 24 hours prior to surgery
  • Body mass index over 35 kg/m2
  • Infection at the injection sites
  • Known allergy to local anesthetics
  • Known psychiatric diseases which prevents communication
  • Operations longer than 3 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group
After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 30 ml of bupivacaine 0.25%.
Procedure: RIB
After endotracheal intubation, patients will be positioned in lateral decubitus position. A RIB will be performed at the level of T5-T6 by ultrasound guidance. A single shot block will be performed by injecting 30 ml of 0.25% bupivacaine to the interfacial plane between rhomboid major muscle and intercostal muscle.
No Intervention: Control Group
No block procedure will be performed in this group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3rd month chronic pain
Time Frame: At the postoperative 3. month
The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.
At the postoperative 3. month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6th month chronic pain
Time Frame: At the postoperative 6. month
The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 6th month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Secondary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 6th month.
At the postoperative 6. month
3rd month total Brief Pain Inventory Short Form Score
Time Frame: At the postoperative 3. month
Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 3rd month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 3rd month.
At the postoperative 3. month
6th month total Brief Pain Inventory Short Form Score
Time Frame: At the postoperative 6. month
Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 6th month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 6th month.
At the postoperative 6. month
3rd month neuropathic pain
Time Frame: At the postoperative 3. month
The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 5th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups.
At the postoperative 3. month
6th month neuropathic pain
Time Frame: At the postoperative 6. month
The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 6th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups at the postoperative 6th month.
At the postoperative 6. month
acute pain
Time Frame: Postoperative 15. minute, 30. minute, 1.hour, 2nd hour, 6th hour, 12th hour, 24th hour
Postoperative acute pain of the patients will be evaluated by using Numerical Rating Scale which ranges between 0 point (no pain) and 10 points (worst pain). The 7th outcome of the study is the difference in numerical rating scale scores between study and control groups.
Postoperative 15. minute, 30. minute, 1.hour, 2nd hour, 6th hour, 12th hour, 24th hour
opioid consumption
Time Frame: Postoperative 24th hour.
Total opioid consumption of the patients will be recorded at the postoperative 24. hour.
Postoperative 24th hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: BAKİYE UĞUR, Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 230022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with anyone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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