Clinical trial

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

Name
11408//15-1-2024
Description
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.
Trial arms
Trial start
2024-02-01
Estimated PCD
2024-08-01
Trial end
2024-09-01
Status
Recruiting
Treatment
normal saline
patients will receive a sham block with 20 ml of normal saline on each side followed by general anesthesia.
Arms:
control group
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.
Arms:
E group
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.
Arms:
R group
Bupivacaine
20 ml of bupivacaine 0.25%
Arms:
E group, R group
Size
72
Primary endpoint
Time to first dose of rescue analgesia
in the first postoperative 24 hours
Total nalbuphine consumption
in the first 24 hours postoperatively
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'computer generating random numbers, the patients will be allocated into three equal groups: Group C: (control group) patients will receive a sham block with 20 ml of normal saline on each side followed by general anesthesia.\n\nGroup E: patients will receive an Erector spinea plane block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.\n\nGroup R: patients will receive rhomboid intercostal nerve block with 20 ml of bupivacaine 0.25% on each side followed by general anesthesia.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double (Participant, Outcomes Assessor) double-blinded(participants and outcome assessors)', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2024-01-26

1 organization

2 products

1 indication

Organization
Zagazig University
Indication
Analgesic