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

NCT06225895 | Completed

• 1 other identifier: 11408//15-1-2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Analgesia

Keywords

Rhomboid Intercostal Block; Erector Spinae Plane Block; Reduction Mammoplasty; Analgesia

Outcome Measures

Primary Outcomes (2)

• Time to first dose of rescue analgesia

  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

  total dose of nalbuphine rescue analgesic that the patient required postoperatively

  in the first 24 hours postoperatively

Secondary Outcomes (2)

• changes of pain assessment

  at 1hour, 3,6,12, 24 hours postoperatively

• non invasive blood pressure

  immediately prior to surgery, immediately after skin incision, 15,30,60,120,180,240 min intraoperatively and at end of surgery

Study Arms (3)

control group

PLACEBO COMPARATOR

patients will receive general anesthesia

Procedure: general anesthesia

E group

ACTIVE COMPARATOR

patients will receive Erector spinae plane block

Procedure: general anesthesia; Procedure: Erector spinae plane block; Drug: Bupivacaine

R group

ACTIVE COMPARATOR

patients will receive rhomboid intercostal nerve block

Procedure: general anesthesia; Procedure: a rhomboid intercostal nerve block; Drug: Bupivacaine

Interventions

general anesthesia PROCEDURE

patients will receive general anesthesia.

E group; R group; control group

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.

E group

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.

R group

Bupivacaine DRUG

20 ml of bupivacaine 0.25%

E group; R group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This surgery is only performed for women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Faculty of medicine, zagazig university

Zagazig, Alsharqia, 4115, Egypt

Location

Shereen E Abd Ellatif

Zagazig, Alsharqia, 4115, Egypt

Location

Related Publications (5)

• Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.

  PMID: 31198256 BACKGROUND

• Viscardi JA, Oranges CM, Schaefer DJ, Kalbermatten DF. Reduction Mammoplasty: A Ten-Year Retrospective Review of the Omega Resection Pattern Technique. J Clin Med. 2021 Sep 27;10(19):4418. doi: 10.3390/jcm10194418.

  PMID: 34640438 BACKGROUND

• 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.

  PMID: 27291611 BACKGROUND

• Tunay DL, Ilginel MT, Karacaer F, Biricik E, Tabakan I, Ozmete O. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Perioperative Analgesia in Breast Reduction Surgery: A Prospective Randomized and Controlled Trial. Aesthetic Plast Surg. 2023 Aug;47(4):1279-1288. doi: 10.1007/s00266-023-03315-0. Epub 2023 Mar 16.

  PMID: 36928313 BACKGROUND

• Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.

  PMID: 30851503 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, General; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Shereen E Abd Ellatif, M.D.

  Faculty of medicine, zagazig university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) double-blinded(participants and outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia and surgical intensive care

Model Details: computer generating random numbers, the patients will be allocated into three equal groups: Group C: (control group) patients will receive general anesthesia. Group E: patients will receive an Erector spinea plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia. Group R: patients will receive rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: planned after the completion of the study and publication
• Access Criteria: contact with principal investigatoR

Locations

EG (2)