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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double (Participant, Outcomes Assessor) double-blinded(participants and outcome assessors)

Study Groups

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control group

patients will receive general anesthesia

Group Type PLACEBO_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

patients will receive general anesthesia.

E group

patients will receive Erector spinae plane block

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

patients will receive general anesthesia.

Erector spinae plane block

Intervention Type PROCEDURE

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

Bupivacaine

Intervention Type DRUG

20 ml of bupivacaine 0.25%

R group

patients will receive rhomboid intercostal nerve block

Group Type ACTIVE_COMPARATOR

general anesthesia

Intervention Type PROCEDURE

patients will receive general anesthesia.

a rhomboid intercostal nerve block

Intervention Type PROCEDURE

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

Bupivacaine

Intervention Type DRUG

20 ml of bupivacaine 0.25%

Interventions

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general anesthesia

patients will receive general anesthesia.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Bupivacaine

20 ml of bupivacaine 0.25%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No