Bilateral Rhomboid Intercostal Block Versus Erector Spinae Plane Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Time to first dose of rescue analgesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) double-blinded(participants and outcome assessors)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
control group
patients will receive general anesthesia
干预措施: general anesthesia (Procedure)
E group
patients will receive Erector spinae plane block
干预措施: general anesthesia (Procedure)
E group
patients will receive Erector spinae plane block
干预措施: Erector spinae plane block (Procedure)
E group
patients will receive Erector spinae plane block
干预措施: Bupivacaine (Drug)
R group
patients will receive rhomboid intercostal nerve block
干预措施: general anesthesia (Procedure)
R group
patients will receive rhomboid intercostal nerve block
干预措施: a rhomboid intercostal nerve block (Procedure)
R group
patients will receive rhomboid intercostal nerve block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to first dose of rescue analgesia
时间窗: 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
时间窗: in the first 24 hours postoperatively
total dose of nalbuphine rescue analgesic that the patient required postoperatively
次要结局
- 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 pain assessment(at 1hour, 3,6,12, 24 hours postoperatively)
研究者
Shereen Elsayed Abd Ellatif
associate professor of anesthesia and surgical intensive care
Zagazig University