Bilateral Rhomboid Intercostal Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty

July 14, 2025 updated by: Shereen Elsayed Abd Ellatif, Zagazig University

Bilateral Rhomboid Intercostal Block Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty

Bilateral reduction mammoplasty is one of the most commonly performed breast surgery. The Postoperative pain following it should be minimized.

Opioid administration for acute pain after reduction mammoplasty surgery has many side effects. Regional block techniques such as paravertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.

The new alternative regional techniques such as erector spinae plane block and rhomboid intercostal plane block are clinical trials for providing a safe, easy, and painless anesthetic procedure with adequate postoperative analgesia for a large section of patients undergoing thoracic surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reduction mammoplasty is the gold standard procedure for symptomatic breast hypertrophy and it is also used for contralateral breast symmetrisation following breast cancer surgery. Symptomatic hypermastia affects the quality of life of millions of women worldwide. The most frequent symptoms shown by more than two-thirds of patients are shoulder grooving, and back, shoulder, and neck pain. Reduction mammoplasty proved to be an effective treatment, both aesthetically and functionally, with a demonstrated consistently high patient satisfaction.

Optimal pain management is an essential component of enhanced recovery after surgery protocols that are becoming standard of care because they have been shown to reduce postoperative complications and expedite recovery. However, postoperative pain is still inadequately managed. Opioids remain the mainstay of perioperative pain management, despite well-recognized adverse events including nausea, vomiting, pruritus, and respiratory depression.

Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Plane blocks such as the serratus anterior plane (SAP) block, pectoral nerve block, and erector spinae plane block have gained popularity during multimodal analgesia after various surgical procedures.

The erector spinae plane block (ESPB) was initially introduced by Forero et al. in 2016 and offers extensive analgesia in thoracic surgery. It can be used as a substitute for PVB because it is less intrusive, simpler, and safer to apply plane blocks that are applied in the plane of the spine's erector muscles.

Rhomboid intercostal block (RIB) was described in 2016 as an alternative to thoracic epidural analgesia. The local anesthetic agent is delivered into the plane between the rhomboid major and intercostal muscles. That provides good analgesia for the anterior and posterior hemithorax.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • 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 Locations

  • Egypt
    • Alsharqia
      • Zagazig, Alsharqia, Egypt, 4115
        • Faculty of Medicine, Zagazig University
      • Zagazig, Alsharqia, Egypt, 4115
        • Shereen E Abd Ellatif

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient acceptance.
  • Age 18-65 years old.
  • BMI ≤ 35 kg/m2
  • ASA I - II.
  • Elective bilateral reduction mammoplasty surgery under general anesthesia.
  • Duration of surgery within five hours

Exclusion Criteria:

  • Patients on anti-platelet, anticoagulant, or B blocker drugs.
  • Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma
  • History of allergy to the local anesthetics (LA) agents used in this study,
  • Skin lesion at the needle insertion site,
  • Those with bleeding disorders, sepsis, liver disease, psychiatric disorders, and pregnancy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: E group
patients will receive Erector spinae plane block
Procedure: Erector spinae plane block
patients will receive Erector spinae plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
Drug: Bupivacaine
20 ml of bupivacaine 0.25%
Procedure: general anesthesia
patients will receive general anesthesia.
Active Comparator: R group
patients will receive rhomboid intercostal nerve block
Drug: Bupivacaine
20 ml of bupivacaine 0.25%
Procedure: a rhomboid intercostal nerve block
patients will receive a rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.
Procedure: general anesthesia
patients will receive general anesthesia.
Placebo Comparator: control group
patients will receive general anesthesia
Procedure: general anesthesia
patients will receive general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first dose of rescue analgesia
Time Frame: in the first postoperative 24 hours
is the time from the end of operation to patient reporting VAS ≥ 3. Thereafter, rescue analgesia in the form of 0.1mg/kg IV of nalbuphine will be injected.
in the first postoperative 24 hours
Total nalbuphine consumption
Time Frame: in the first 24 hours postoperatively
total dose of nalbuphine rescue analgesic that the patient required postoperatively
in the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of pain assessment
Time Frame: at 1hour, 3,6,12, 24 hours postoperatively
visual analogue scale will be recorded at rest and movement
at 1hour, 3,6,12, 24 hours postoperatively
non invasive blood pressure
Time Frame: immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery
changes of hemodynamics
immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Shereen E Abd Ellatif, M.D., Faculty of Medicine, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11408//15-1-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

planned after the completion of the study and publication

IPD Sharing Time Frame

planned after the completion of the study and publication

IPD Sharing Access Criteria

contact with principal investigatoR

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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