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临床试验/NCT07759570
NCT07759570尚未招募不适用

The Effect of Superficial Parasternal Intercostal Plane Catheter Analgesia Following Sternotomy in Coronary Artery Bypass Surgery on Postoperative Pain: A Prospective Randomized Controlled Trial

Koc University Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers. This study investigates whether placing a catheter to deliver a local anesthetic to the superficial parasternal intercostal plane reduces pain following this type of heart surgery. Patients undergoing CABG via sternotomy will be randomly assigned to either the catheter-based analgesia group or the standard pain management group. The researchers will compare postoperative pain levels and analgesic medication requirements between the two groups to determine whether this technique improves postoperative pain control.

详细描述

Patients undergoing coronary artery bypass surgery will be included. Patients will be divided into two groups: the block group, in which a bilateral superficial parasternal plexus catheter will be inserted, and the control group, in which no parasternal plexus block or catheter will be administered.

In the block group, the catheter placement will be performed after completion of the surgery and before the patient is transferred to the ICU, under ultrasound guidance (Venue Go, GE, L4-T12 high-frequency linear probe). The probe will be positioned transversely across the costal cartilage, parallel to the sternum, in a parasagittal orientation at the level of 3rd rib. A 5-cm Tuohy needle will be inserted 2 cm lateral to the midline and advanced between the pectoralis major and external intercostal muscles at the third parasternal intercostal space. Needle tip position will be confirmed by negative aspiration for blood or air, followed by injection of 20 mL of bupivacaine 0.2% into the parasternal plane. Correct needle position will be confirmed by visualization of local anesthetic spread and hydrodissection separating the pectoralis major from the ribs and external intercostal muscles. A catheter (Tuohy Ultra-360 18G, B. Braun Contiplex, 400 mm) will then be placed into the parasternal intercostal space. Catheter position will be confirmed by ultrasound visualization of spread of 10 mL saline, after which the catheter will be secured. The procedure will be performed bilaterally. Postoperatively, 20 mL of bupivacaine 0.2% will be administered by the clinician through each parasternal catheter at 12, 24, 36, 48, 60, and 72 hours. Catheters will be removed by the clinician at 72 hours. Catheter-related complications, including bleeding, infection, and dislocation, will be recorded.

In the control group, no parasternal plexus block or catheter will be placed.

Intraoperative anesthesia technique will be identical in both groups. All patients will be admitted to the ICU orotracheally intubated and will be extubated in the ICU rather than in the operating room.

Pain nurses will assess all patients every 12 hours for 72 hours postoperatively. At each visit, pain score will be recorded using the Visual Analog Scale, where 0 corresponds to no pain and 10 corresponds to worst pain, assessed both at rest and during movement. Postoperative opioid consumption will be monitored via a patient-controlled analgesia device. The Morphine PCA solution will be prepared at a concentration of 1 mg/mL, with no background infusion, a bolus dose of 1 mL, and a lockout interval of 15 minutes. Additional (rescue) opioid analgesic requirements will be recorded by pain monitoring nurses. Rescue analgesia in both groups will consist of tramadol 1 mg/kg administered intravenously.

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
None

盲法说明

Statistician

入排标准

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

入选标准

  • •- Adult patients with coronary artery disease scheduled for coronary artery bypass graft surgery

排除标准

  • •Under 18 years of age
  • •ASA (American Society of Anesthesiologists) Class V patients
  • •Non-elective emergency cases
  • •Patient refusal to participate in the study
  • •Language barrier
  • •Patients who have previously undergone sternotomy
  • •History of significant psychiatric disorders
  • •Patients with known long-term opioid use
  • •Patients with potential contraindications to nerve blocks (bleeding diathesis, infection, and allergy to local anesthetics)
  • •Patients with an ejection fraction <40%
  • •Patients with right ventricular systolic dysfunction (patients with TAPSE <1.8 cm)
  • •Patients with a left atrial diameter >4 cm
  • •Patients with severe valvular heart disease
  • •Patients undergoing concomitant valvular heart surgery
  • •Patients with a history of atrial flutter and/or atrial fibrillation

研究组 & 干预措施

Block group

Active Comparator

Patiens receiving bilateral superficial parasternal catheter at the end of the surgery

干预措施: Parasternal blocks (Other)

Control group

No Intervention

No superficial parasternal catheter will be placed

结局指标

主要结局

Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).

时间窗: Postoperative 24 hours

Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively

次要结局

  • Length of hospital stay(From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission)
  • Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery(at 12, 24, 36, 48, 60, and 72 hours post-Surgery)
  • NRS pain scores associated with coughing at 12, 24, 36, 48, 60, and 72 hours post-Surgery(at 12, 24, 36, 48, 60, and 72 hours post-Surgery)
  • Total amount of opioids consumed during the first 72 hours after surgery(at the first 72 hours after surgery)
  • Time to first rescue analgesic administration(The patient will be monitored for the first 72 hours after surgery.)
  • Time to extubation (in minutes) following admission to the postoperative intensive care unit(From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission)
  • Length of stay in the intensive care unit(From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission)
  • Assessment of Patient Satisfaction Using a numeric rating scale(at the 72nd hour postoperatively)
  • Bleeding associated with a peripheral block catheter(for 72 hours after surgery)
  • Postoperative Nausea and Vomiting(for 72 hours after surgery)
  • Time to first bowel movement(for 72 hours after surgery)
  • Postoperative arrhythmia(During the first 72 hours after surgery)
  • Postoperative catheter-site infection(From the end of the surgery until hospital discharge, assessed up to 30 days after surgery)
  • Dislocation of the parasternal block catheter(During the first 72 hours after surgery)

研究者

发起方
Koc University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafet Onur Gorgulu

MD, Resident

Koc University Hospital

研究点 (1)

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