Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery (PINB-CPSP)
Effect of Ultrasound-Guided Preemptive Parasternal Intercostal Nerve Block on the Incidence of Chronic Pain After Cardiac Surgery Via Sternotomy: A Prospective Randomized Controlled Trial
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Effective control of pain in the early postoperative period is thought to reduce the central sensitisation that drives the transition from acute to chronic pain.
This single-centre, prospective, randomised, patient- and assessor-blinded controlled trial investigates whether an ultrasound-guided bilateral parasternal intercostal nerve block, performed preemptively after induction of general anaesthesia and before surgical incision, reduces the incidence of chronic pain three months after cardiac surgery performed through a median sternotomy.
A total of 174 adults scheduled for elective cardiac surgery will be randomised in a 1:1 ratio to receive either the block plus the institution's standard multimodal analgesia protocol, or the standard protocol alone. The primary endpoint is the incidence of chronic post-sternotomy pain at three months, assessed with the Turkish version of the Brief Pain Inventory - Short Form. Secondary endpoints cover acute pain scores, opioid consumption, postoperative nausea and vomiting, and complications.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Design and setting. The trial will be conducted in the Department of Anesthesiology and Reanimation, University of Health Sciences Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Eligible patients will be identified at the preoperative anaesthesia assessment and written informed consent will be obtained.
Randomisation and blinding. Participants will be allocated 1:1 using sequentially numbered, opaque, sealed envelopes prepared in advance. Patients and the investigator performing postoperative assessments will be unaware of group assignment; the anaesthesiologist performing the block cannot be blinded.
Intervention. In the block group, after induction of general anaesthesia and before surgical incision, a bilateral parasternal intercostal nerve block will be performed in the supine position with a high-frequency linear ultrasound probe (6-15 MHz) and a 22 G, 80 mm echogenic block needle.
Anaesthetic and analgesic management, identical in both groups.
Assessments. Pain is scored with the Numeric Rating Scale at rest and on movement at 1, 6, 12 and 24 hours after extubation. Opioid consumption, postoperative nausea and vomiting and any complications are recorded. At three months patients are contacted by telephone and assessed with the Brief Pain Inventory - Short Form, validated in Turkish by Ataman and colleagues.
Sample size. The calculation is based on the primary endpoint. 87 participants per group will be enrolled, for a total of 174.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ilayda Kalyoncu Karahan, MD
- 전화번호: 00905325105014
- 이메일: ilaydaakalyoncu@gmail.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Age between 18 and 75 years
- Scheduled for elective cardiac surgery via median sternotomy
- Able to understand and use the Numeric Rating Scale for pain
- Willing to participate and able to provide written informed consent
Exclusion Criteria:
- Surgery planned by a minimally invasive or thoracoscopic approach
- Refusal to participate
- Known allergy to the local anaesthetics or analgesics to be used
- Chronic opioid use
- Coagulopathy
- Infection at the planned block site
- Pregnancy or lactation
- Inability to communicate or to score pain reliably
- Psychiatric or neurological condition preventing reliable completion of the BPI-SF and NRS assessments
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: PINB Group
After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol.
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Performed in the supine position after induction of general anaesthesia and before surgical incision, using a 6-15 MHz linear ultrasound probe and a 22 G, 80 mm echogenic block needle.
0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block.
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간섭 없음: Control Group
No regional block is performed.
Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of chronic post-sternotomy pain at three months
기간: 3 months after surgery
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3 months after surgery
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Incidence of chronic post-sternotomy pain at three months
기간: 3 months after surgery
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Proportion of participants reporting pain in the sternotomy region three months after surgery, assessed by telephone with the Turkish Brief Pain Inventory - Short Form (BPI-SF).
Chronic pain is defined as a reported pain score above 0 on the 0-10 numeric scale, at rest or on movement, persisting for more than three months after the operation.
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3 months after surgery
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공동 작업자 및 조사자
스폰서
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026/310
- 2026-18-08 (기타 식별자: Bakirkoy Dr. Sadi Konuk Training and Research Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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