Serratus Posterior Superior Intercostal Plane Block in Port Catheter Implantation
Comparison of Serratus Posterior Superior Intercostal Plane Block and Local Infiltration for Analgesia During Port Catheter Implantation: A Prospective Randomized Study
연구 개요
상태
상세 설명
This prospective, randomized controlled study evaluates the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block compared with standard local anesthetic infiltration in patients undergoing port catheter implantation. Although the procedure is usually performed under local anesthesia, patients may experience significant pain during port pocket creation.
Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided SPSIP block or local anesthetic infiltration. All patients will receive standardized monitoring and premedication. Pain intensity during different procedural stages, postoperative pain scores, analgesic consumption, and satisfaction levels will be assessed.
The study aims to determine whether SPSIP block improves intraoperative analgesia and reduces analgesic requirements compared to local infiltration.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Outside of the US
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Diyarbakır, Outside of the US, 터키 (Türkiye), 21070
- Fatma Acil
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-75 years
- ASA physical status I-III
- Scheduled for elective port catheter implantation
- Ability to understand and use the Numeric Rating Scale (NRS)
- Provided written informed consent
Exclusion Criteria:
- Known allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or anticoagulant therapy
- Severe pulmonary disease
- G6PD deficiency
- Pregnancy or breastfeeding
- Inability to assess pain or communicate effectively
- Refusal to participate
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Local Infiltration
Participants will receive standard local anesthetic infiltration during port catheter implantation.
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Standard local anesthetic infiltration performed at the surgical site during port catheter implantation.
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실험적: Serratus Posterior Superior Intercostal Plane Block
Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation.
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Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain intensity during port pocket creation
기간: During procedure
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Pain intensity during port pocket creation measured using the Numeric Rating Scale (0-10), where higher scores indicate greater pain. Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. |
During procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum intraoperative pain score
기간: During the procedure
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The highest pain intensity recorded during any procedural stage will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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During the procedure
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Pain intensity during procedural stages
기간: During the procedure
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Pain intensity will be assessed during skin puncture, catheter tunneling, and skin closure using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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During the procedure
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Total supplemental local anesthetic amount
기간: During the procedure
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Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters.
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During the procedure
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Postoperative pain scores
기간: 0, 2, 6, 12, and 24 hours after the procedure
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Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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0, 2, 6, 12, and 24 hours after the procedure
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Total tramadol consumption
기간: Within 24 hours after the procedure
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Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams.
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Within 24 hours after the procedure
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Duration of effective analgesia
기간: Within 24 hours after the procedure
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Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia.
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Within 24 hours after the procedure
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Patient satisfaction score
기간: After the procedure
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Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
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Surgeon satisfaction score
기간: After the procedure
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Surgeon satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Higher scores indicate greater satisfaction.
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After the procedure
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Procedure-related complications
기간: During and within 24 hours after the procedure
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Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded.
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During and within 24 hours after the procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- 07/04/2026-123
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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