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

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Procedure: general anesthesia; Procedure: Erector spinae plane block; Procedure: a rhomboid intercostal nerve block; Drug: Bupivacaine

• Registration Number: NCT06225895
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-26
• Study Start: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E group	Erector spinae plane block	patients will receive Erector spinae plane block
control group	general anesthesia	patients will receive general anesthesia
E group	Bupivacaine	patients will receive Erector spinae plane block
E group	general anesthesia	patients will receive Erector spinae plane block
R group	general anesthesia	patients will receive rhomboid intercostal nerve block
R group	a rhomboid intercostal nerve block	patients will receive rhomboid intercostal nerve block
R group	Bupivacaine	patients will receive rhomboid intercostal nerve block

Primary Outcome Measures

Name	Time	Method
Time to first dose of rescue analgesia	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.
Total nalbuphine consumption	in the first 24 hours postoperatively	total dose of nalbuphine rescue analgesic that the patient required postoperatively

Secondary Outcome Measures

Name	Time	Method
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	changes of hemodynamics
changes of pain assessment	at 1hour, 3,6,12, 24 hours postoperatively	visual analogue scale will be recorded at rest and movement

Trial Locations

Locations (2)

Shereen E Abd Ellatif; 🇪🇬 Zagazig, Alsharqia, Egypt

Faculty of medicine, zagazig university; 🇪🇬 Zagazig, Alsharqia, Egypt