이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Parasternal Intercostal Plane Catheter for Pain Control After CABG Surgery (PIP-PAIN)

2026년 8월 6일 업데이트: Rafet Onur Gorgulu, Koc University Hospital

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

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

Patients' heart rhythm will be monitored continuously via telemetry throughout their hospital stay. Atrial tachyarrhythmias, including atrial flutter and atrial fibrillation, will be recorded throughout the hospital stay. Nausea, vomiting, and constipation will be recorded for 72 hours postoperatively.

Patient satisfaction will be assessed using a 5-point Likert scale, where 1 corresponds to strongly not satisfied and 5 corresponds to strongly satisfied. Hospital length of stay, ICU length of stay, and time to extubation in the ICU will be recorded for both groups.

연구 유형

중재적

등록 (추정된)

56

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Zeytinburnu
      • Istanbul, Zeytinburnu, 터키 (Türkiye), 34010
        • Koc University Hospital
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Block group
Patiens receiving bilateral superficial parasternal catheter at the end of the surgery
Bilateral superficial parasternal block catheters will be placed at the end of the surgery, at the level of 3rd rib using ultrasound guidance
간섭 없음: Control group
No superficial parasternal catheter will be placed

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cumulative opioid consumption at 24 hours post-operatively (mg morphine equivalent).
기간: Postoperative 24 hours
Cumulative opioid consumption (patient controlled analgesia and rescue analgesia) at the first 24 hours postoperatively
Postoperative 24 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Resting NRS pain scores at 12, 24, 36, 48, 60, and 72 hours post-Surgery
기간: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Resting pain levels of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
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
기간: at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Pain levels associated with cough of patients will be evaluated using the numeric rating scale where 0 point meaning no pain and 10 points meaning the worst pain possible
at 12, 24, 36, 48, 60, and 72 hours post-Surgery
Total amount of opioids consumed during the first 72 hours after surgery
기간: at the first 72 hours after surgery
at the first 72 hours after surgery
Time to first rescue analgesic administration
기간: The patient will be monitored for the first 72 hours after surgery.
The time when rescue analgesia is first administered during the postoperative recovery period
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
기간: From intensive care unit admission until extubation, assessed up to 72 hours after intensive care unit admission
It will be recorded as postoperative minutes.
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
기간: From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
From intensive care unit admission until ICU discharge, assessed up to 14 days after intensive care unit admission
Length of hospital stay
기간: From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
From surgery until hospital discharge, assessed up to 30 days after intensive care unit admission
Assessment of Patient Satisfaction Using a numeric rating scale
기간: at the 72nd hour postoperatively
Patients will be asked "How satisfied are you with your pain treatment" at 72 hours after surgery. A numeric rating scale will be used where 0 point meaning not satisfied at all and 10 points meaning can not be satisfied more.
at the 72nd hour postoperatively
Bleeding associated with a peripheral block catheter
기간: for 72 hours after surgery
for 72 hours after surgery
Postoperative Nausea and Vomiting
기간: for 72 hours after surgery
for 72 hours after surgery
Time to first bowel movement
기간: for 72 hours after surgery
Postoperative time to first bowel movement (defecation or flattus)
for 72 hours after surgery
Postoperative arrhythmia
기간: During the first 72 hours after surgery
Patients will be monitored via telemetry during their discharge period.
During the first 72 hours after surgery
Postoperative catheter-site infection
기간: From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
From the end of the surgery until hospital discharge, assessed up to 30 days after surgery
Dislocation of the parasternal block catheter
기간: During the first 72 hours after surgery
After the catheter is placed using ultrasound, the catheter site will be verified with saline.
During the first 72 hours after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 30일

기본 완료 (추정된)

2026년 10월 30일

연구 완료 (추정된)

2026년 11월 15일

연구 등록 날짜

최초 제출

2026년 7월 31일

QC 기준을 충족하는 최초 제출

2026년 8월 6일

처음 게시됨 (실제)

2026년 8월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 6일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Anonymized patient data will be published in a public repository

IPD 공유 기간

Starting at the completion of the study (anticipated November 2026) with no end date

IPD 공유 액세스 기준

Anonymized patient data will be open to be accessed by any researcher

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다