SPSIP Versus RISS Block in Volume-Preserving VATS (SRVATS)
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal-Subserratus Plane Block on Postoperative Analgesia and Respiratory Functions in Volume-Preserving Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial
연구 개요
상태
상세 설명
Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain that may impair respiratory function and delay recovery. Regional anesthesia techniques are increasingly used to improve analgesia while minimizing opioid-related adverse effects.
The Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Rhomboid Intercostal and Subserratus (RISS) block are novel ultrasound-guided fascial plane blocks that provide thoracic analgesia through different mechanisms. However, comparative clinical evidence regarding their efficacy in VATS patients remains limited.
This prospective, randomized, controlled study will enroll 84 adult patients scheduled for volume-preserving VATS. Participants will be randomly assigned to receive either SPSIP block or RISS block in a 1:1 ratio (42 patients per group).
The primary endpoint is the incidence of somatic pain at the chest drain insertion site at postoperative 2 hours.
Secondary endpoints include postoperative pain scores at rest and during movement, total intravenous morphine consumption during the first 24 postoperative hours, Quality of Recovery-15 (QoR-15) score at postoperative 24 hours, diaphragmatic excursion measured by ultrasonography, peak expiratory flow measurements, rescue analgesic requirements, time to first rescue analgesia, incidence of postoperative nausea and vomiting, and block-related complications.
The study has been approved by the Bursa Sehir Hospital Clinical Research Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yusuf Alan
- 전화번호: +905396210977
- 이메일: dryusufalan@gmail.com
연구 장소
-
-
Nilüfer
-
Bursa, Nilüfer, 터키 (Türkiye), 16100
- Bursa City Hospital
-
연락하다:
- Yusuf Alan, MD
- 전화번호: 05396210977
- 이메일: dryusufalan@gmail.com
-
수석 연구원:
- Yusuf Alan, MD
-
부수사관:
- Onur Gunes, MD
-
부수사관:
- Halil ERTEK, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients scheduled for elective biportal video-assisted thoracoscopic surgery (VATS) with lung parenchyma-preserving thoracic procedures under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Age between 18 and 75 years
- Provision of written informed consent
Exclusion Criteria:
- Use of anticoagulant or antiplatelet therapy
- Bleeding diathesis
- Known allergy to local anesthetics
- Infection at the planned block site
- Severe chronic pulmonary disease or advanced respiratory failure (e.g., severe COPD or restrictive lung disease)
- Cognitive impairment preventing reliable NRS assessment
- Pregnancy or lactation
- Chronic opioid use (regular use for ≥3 months)
- Severe hepatic or renal failure
- Refusal to participate
- Technical failure or unsuccessful regional block
- Conversion to open thoracotomy during surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: SPSIP Block Group
Patients will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).
|
Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.
|
|
실험적: RISS Block Group
Patients will receive an ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block before induction of general anesthesia for postoperative analgesia after video-assisted thoracic surgery (VATS).
|
Ultrasound-guided Rhomboid Intercostal and Subserratus (RISS) block performed before induction of general anesthesia using local anesthetic for postoperative analgesia in patients undergoing video-assisted thoracic surgery.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Somatic Pain at Chest Tube Insertion Site
기간: Postoperative 2 hours
|
Incidence of somatic pain localized at the chest tube insertion site, defined as sharp localized pain aggravated by coughing or deep inspiration, recorded as present or absent.
|
Postoperative 2 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Pain Scores at Rest
기간: Postoperative 2, 6, 12, and 24 hours
|
Static postoperative pain scores assessed using the Numeric Rating Scale (NRS) at rest.
|
Postoperative 2, 6, 12, and 24 hours
|
|
Postoperative Pain Scores During Movement
기간: Postoperative 2, 6, 12, and 24 hours
|
Dynamic postoperative pain scores assessed using the Numeric Rating Scale (NRS) during movement.
|
Postoperative 2, 6, 12, and 24 hours
|
|
Total Intravenous Morphine Consumption
기간: Postoperative 24 hours
|
Total intravenous morphine consumption during the first 24 hours after surgery.
|
Postoperative 24 hours
|
|
Interval Intravenous Morphine Consumption
기간: Postoperative 0-8, 8-16, and 16-24 hours
|
Intravenous morphine consumption recorded separately for postoperative 0-8, 8-16, and 16-24 hour intervals.
|
Postoperative 0-8, 8-16, and 16-24 hours
|
|
Right Hemidiaphragm Excursion
기간: Preoperative and postoperative 6 hours
|
Right hemidiaphragm excursion measured by ultrasonography to evaluate diaphragmatic function.
|
Preoperative and postoperative 6 hours
|
|
Peak Expiratory Flow
기간: Preoperative and postoperative 6 hours
|
Peak expiratory flow measured using a peak flowmeter to evaluate respiratory performance.
|
Preoperative and postoperative 6 hours
|
|
Quality of Recovery-15 Score
기간: Postoperative 24 hours
|
Postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
|
Postoperative 24 hours
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 26-AKD-150
- 2025-KAEK-47 (기타 식별자: Bursa City Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
수술 후 통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Serratus posterior superior intercostal plane block에 대한 임상 시험
-
Bursa City Hospital모병어깨 통증 | 수술 후 통증, 급성 | Serratus 후방 상부 늑간 평면 블록터키 (Türkiye)
-
Antalya City Hospital아직 모집하지 않음
-
BEDİA MİNE HANEDAN완전한
-
Fondazione Policlinico Universitario Agostino Gemelli...모병수술 후 통증 관리 | 국소마취 | 흉선절제술 | Serratus 후방 상부 늑간 평면 블록 | 쥐 수술 | 로봇 보조 흉강경 수술이탈리아
-
Ospedale di CamposampieroAzienda Ulss 6 Euganea아직 모집하지 않음통증, 수술 후 | 유방암 | 마취 | 유방절제술
-
Zonguldak Bulent Ecevit University완전한
-
Cairo UniversitySamuel Bekhet Moawad; Ahmed Shaker Ragab; Michael Wahib Wadid완전한U/S 유도 SAB VS U/S 유도 SAB 변형 가슴 신경 차단과 결합이집트