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

Z

Zagazig University

Status

Enrolling

Conditions

Analgesia

Treatments

Procedure: a rhomboid intercostal nerve block
Drug: Bupivacaine
Procedure: Erector spinae plane block
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06225895
11408//15-1-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

Female

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

72 participants in 3 patient groups, including a placebo group

control group
Placebo Comparator group
Description:
patients will receive a sham block
Treatment:
Drug: normal saline
E group
Active Comparator group
Description:
patients will receive Erector spinae plane block
Treatment:
Procedure: Erector spinae plane block
Drug: Bupivacaine
R group
Active Comparator group
Description:
patients will receive rhomboid intercostal nerve block
Treatment:
Drug: Bupivacaine
Procedure: a rhomboid intercostal nerve block

Trial contacts and locations

0

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Central trial contact

Shereen E Abd Ellatif, M.D.; Rehab A Wahdan, M.D.

Data sourced from clinicaltrials.gov

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