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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225895
• Other study ID #: 11408//15-1-2024
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Zagazig University
• Contact: Shereen E Abd Ellatif, M.D.
• Phone: +20552336654
• Email: shosh.again[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient acceptance.

• Age 21-50 years old.

• BMI = 30 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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• normal saline
patients will receive a sham block with 20 ml of normal saline on each side followed by general anesthesia.

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.
• 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.

Drug:
• Bupivacaine
20 ml of bupivacaine 0.25%

Locations

Country	Name	City	State
Egypt	Faculty of medicine, zagazig university	Zagazig	Alsharqia
Egypt	Shereen E Abd Ellatif	Zagazig	Alsharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total nalbuphine consumption	total dose of nalbuphine rescue analgesic that the patient required postoperatively	in the first 24 hours postoperatively
Secondary	changes of pain assessment	visual analogue scale will be recorded at rest and movement	at 1hour, 3,6,12,18, 24 hours postoperatively
Secondary	non invasive blood pressure	changes of hemodynamics	immediately prior to surgery, intraoperative (every 5 minutes for the first 20 minutes of the surgery then every 15 minutes till the end of surgery)