Role of Transversus Thoracis Plane Block Versus Parasternal Intercostal Nerve Plane Block in Enhanced Recovery Program After Cardiac Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The first requirement for analgesia:
研究概览
简要总结
Traditionally postoperative pain management after cardiac surgery has been based on opiate analgesics. However, opiates have some undesirable dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which substantially influence patient recovery and may delay discharge after surgery.
The American Society of Anesthesiologists has endorsed multi- modal analgesia, involving multiple analgesics with differing modes of action, to reduce the overreliance on opioid-based postsurgical analgesic regimens and the associated adverse effects.
The safety of using the transversus thoracis muscle plane block (TTP) or the parasternal intercostal nerve block (PSI block) for cardiac surgeries allow to make the option of using opioids alone and the possibility of its complications not the rule in post-operative pain relief in cardiac surgeries.
In the current study, improving the quality of the transversus thoracis muscle plane block (TTP) or the parasternal intercostal nerve block (PSI block) for cardiothoracic surgeries by enhancing post-operative pain relief becomes more and more required to cope up with the new surgical modalities.
详细描述
Enhanced Recovery After Surgery (ERAS) is an international effort to develop perioperative programs aimed at optimizing patient outcomes and healthcare delivery efficiency. These programs are composed of intervention bundles based on the principles of best practice, standardized and consistent healthcare delivery, regular audit, and team feedback, all with a patient-centered focus. Implementation of such programs has resulted in patient and healthcare benefits, including promising early results within the cardiac surgical community.
A perioperative, multimodal, opioid-sparing, pain management plan is classified as B-NR (B-level evidence, nonrandomized studies) in the classification of recommendation and level of evidence. The ERAS Cardiac Society's grading of this recommendation is appropriate because it is a laudable goal that requires additional research. Areas of investigation to refine postoperative pain management include the following: managing patient and provider expectations, individualizing the dose and types of analgesics, consideration of the potential cardioprotective effects of opioids, and incorporating nonpharmacologic approaches to pain management such as regional anesthesia.
Pain after cardiac surgery is caused by several factors; sternotomy, sternal/rib retraction, pericardiotomy, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma during surgery.
Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control may have adverse pathophysiologic sequelae, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for thromboembolic events. These adverse events may result in greater perioperative morbidity and mortality.
Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains elusive.
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 blinded (patient and outcomes assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient acceptance.
- •Sex: both; male and female
- •Age (21-60) years old.
- •American society of anesthesiology (ASA): II and III.
- •Body mass index (BMI) >35 kg/m2
- •Elective cardiac surgeries requiring median sternotomy.
- •Accepted mental state of the patient.
- •Non-smoker or ex-smoker for more than one month.
- •Optimal preoperative glycemic control, defined by a hemoglobin A1c level less than 6.5%.
排除标准
- •Patient refusal and lack of informed consent.
- •Emergency or non-median sternotomy surgery.
- •History of allergy to local anesthetics (lidocaine or bupivicaine).
- •Coexisting hematologic disorders or malnourished patient.
- •Pre-existing major organ dysfunction including hepatic or renal failure, and left ventricular ejection fraction <30%
- •Peripheral neuropathy.
- •Pregnancy.
- •Patients with a diagnosis of cognitive impairment.
- •Significant psychiatric illnesses including schizophrenia, bipolar disorder, uncontrolled anxiety, or depression.
研究组 & 干预措施
The transversus thoracis muscle plane block (TTP) group
Patients will receive the TTP block with administration of 20 ml volume of local anesthetics (Lidocaine 2% + Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone) bilaterally
干预措施: transversus thoracis muscle plane block (TTP) (Drug)
The parasternal intercostal nerve block (PSI block) group
Patients will receive the PSI block with administration of 20 ml volume of local anesthetics (Lidocaine 2% + Bupivicaine 0.5% 1:1 mixture + 8mg dexamethasone) bilaterally
干预措施: parasternal intercostal nerve block (PSI block) (Drug)
结局指标
主要结局
The first requirement for analgesia:
时间窗: within 24 hour postoperative
The time from injection of LA to patient first request of analgesia
change in assessment of postoperative pain will be assessed by visual analogue scale (VAS) scale
时间窗: at 1, 2, 3, 4, 8, 12, 16, 20 and 24 hours postoperatively
scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
次要结局
- Extubation time(within 24 hour postoperative)
- ICU stay(within 24 hour postoperative)
- Total amount of morphine consumed(within 24 hour postoperative)
研究者
Rehab Abd-Allah Wahdan
lecturer of anesthesia and surgical intensive care
Zagazig University