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NCT Number: NCT06225895

Bilateral Rhomboid Intercostal 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, zagazig university, Zagazig, Alsharqia, Egypt

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General Anesthesia

Procedure

patients will receive general anesthesia.

Erector Spinae Plane Block

Procedure

patients will receive Erector spinae plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.

a rhomboid intercostal nerve block

Procedure

patients will receive a rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Bupivacaine

Drug

20 ml of bupivacaine 0.25%

Primary outcomes

  1. 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.

  2. Total nalbuphine consumption

    Time frame: in the first 24 hours postoperatively

    total dose of nalbuphine rescue analgesic that the patient required postoperatively

Secondary outcomes

  1. changes of pain assessment

    Time frame: at 1hour, 3,6,12, 24 hours postoperatively

    visual analogue scale will be recorded at rest and movement

  2. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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