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临床试验/NCT06210126
NCT06210126已完成不适用

Effect of Pectointercostal Fascial Plane (PIF) Block on Postoperative Chronic Pain in Patients Undergoing Open Heart Surgery: Randomized, Controlled Study

Konya Meram State Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
chronic pain

研究概览

简要总结

This study aims to compare the effect of pectointercostal fascial plane block (PIFB) on postoperative chronic pain in patients undergoing open heart surgery with the standard multimodal analgesia technique.

详细描述

Chronic postsurgical pain (CPSP), defined as persistent pain at the surgical site or referred areas lasting at least three months post-surgery, poses a considerable challenge, notably after median sternotomy in cardiac procedures. Incidence rates, ranging from 28% to 56% within two years post-operation, exhibit variability, partly due to diverse presentations and potential underreporting by patients. The psychological impact of cardiac surgery often leads patients to normalize enduring pain, delaying the identification of chronic post-sternotomy pain.

The multifaceted etiology of CPSP after sternotomy remains incompletely understood. Factors such as neural sensitization during the acute phase, neuropathy from nerve entrapment or injury during surgery, musculoskeletal trauma from incisions, sternal complications, and infections contribute to this complex pain landscape. Inadequate management of acute perioperative pain can trigger central sensitization, a process-altering spinal pain pathway, and predispose individuals to hyperalgesia and chronic pain. Thus, effective acute pain control not only alleviates immediate postoperative discomfort but also potentially averts the onset of chronic pain.

Traditionally, opioids like fentanyl and morphine have been primary choices for post-cardiac surgery pain relief. However, their use is associated with dose-related side effects such as nausea, respiratory issues, chronic opioid dependence, and increased chronic pain risk. Implementing a multimodal approach, including NSAIDs, proves challenging due to bleeding and renal complications post-cardiac surgery. In contrast, regional analgesia offers an opioid-sparing alternative. Parasternal regional blocks like the pectointercostal fascial plane block (PIFB) present a low-risk option and have demonstrated efficacy in alleviating acute post-sternotomy pain.

Addressing this, a prospective, double-blinded randomized controlled trial aimed to evaluate whether a PIF block could provide effective perioperative analgesia and potentially mitigate the incidence of CPSP in patients undergoing sternotomy for cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 3 risk score patients scheduled for elective open heart surgery

排除标准

  • Emergent surgery
  • Previous thoracotomy
  • LVEF <30
  • Patients with psychiatric disorders
  • Presence of hematological disease
  • Patients with alcohol-drug addiction
  • Patients who use daily opioids for any reason
  • Chronic analgesic use
  • Allergy to local anesthetics

结局指标

主要结局

chronic pain

时间窗: 3 months

Postoperative chronic pain will be evaluated using brief pain inventory at 3 months after cardiac surgery. Brief Pain Inventory is a questionnaire designed to capture both pain intensity and the amount of interference that pain has on functioning. Pain intensity is measured with four items (worst, least, on average, and currently). Interference is measured with seven items, including general activity, mood, walking, work (including paid and household work), relations with others, sleep, and enjoyment of life. The patient answers the items on a scale of 0-10, the highest number indicating the worst imaginable pain for intensity items and complete interference for interference items.

次要结局

  • Time to extubation(24 hour)
  • Length of stay in the ICU(7 day)
  • The number of patients who required rescue analgesic(72 hour)
  • Postoperative pain score(72 hour)
  • Postoperative nausea and vomiting (PONV)(72 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Kozanhan

Prof. Dr

Konya Meram State Hospital

研究点 (2)

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