Nephrostomy Tract Infiltration for Pain Control After PCNL
Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial
This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Eligible patients will be randomly assigned to either a control group receiving standard systemic postoperative analgesia or an intervention group receiving standard analgesia plus infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract at the end of surgery. Postoperative pain will be assessed using the Visual Analog Scale at 1, 6, 12, and 24 hours. Secondary outcomes will include time to first analgesic requirement, total opioid consumption during the first 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and treatment-related complications. The study is designed to determine whether nephrostomy tract infiltration provides a simple, safe, and effective adjunct for reducing pain and analgesic consumption after percutaneous nephrolithotomy.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: MUSTAFA SERDAR ÇAĞLAYAN
- 전화번호: +905074311951
- 이메일: serdar.09.09@hotmail.com
연구 장소
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Çorum
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Çorum, Çorum, 터키 (Türkiye), 19040
- 모병
- Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
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부수사관:
- AHMET TAŞCI
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연락하다:
- MUSA EKİCİ
- 전화번호: +90 505 751 6341
- 이메일: musaekici@hitit.edu.tr
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부수사관:
- METİN KIZGIN
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 18 to 75 years
- Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
- Classified as American Society of Anesthesiologists (ASA) physical status I-III
- Able to understand and complete postoperative pain assessments using the Visual Analog Scale (VAS)
- Willing to participate in the study
- Provision of written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to bupivacaine or other local anesthetic agents
- Coagulopathy or clinically significant bleeding disorder
- Chronic opioid use
- History of a neurological disorder that may affect pain perception or assessment
- Neurological or psychiatric condition preventing reliable postoperative pain assessment
- Active urinary tract infection or sepsis
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Requirement for multiple percutaneous access tracts
- Bilateral percutaneous nephrolithotomy
- Requirement for postoperative intensive care
- Refusal or inability to provide written informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Nephrostomy Tract Bupivacaine Infiltration
Participants in this arm will receive standard postoperative systemic analgesia. In addition, at the end of percutaneous nephrolithotomy, 20 mL of 0.25% bupivacaine will be infiltrated along the nephrostomy tract, including the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract. |
A total of 20 mL of 0.25% bupivacaine will be administered by local infiltration along the nephrostomy tract at the end of surgery. The infiltration will include the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.
다른 이름들:
Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.
다른 이름들:
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활성 비교기: Standard Systemic Analgesia
Participants in this arm will receive the standard postoperative systemic analgesia protocol, including intravenous tramadol and intravenous paracetamol. Rescue opioid analgesia will be administered when clinically required. No local or regional analgesic intervention will be performed. |
Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Pain Intensity Assessed Using the Visual Analog Scale
기간: At 1, 6, 12, and 24 hours after surgery
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Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS). Patients will rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the nephrostomy tract bupivacaine infiltration group and the standard systemic analgesia group. |
At 1, 6, 12, and 24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to First Rescue Analgesic Requirement
기간: From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours
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The time from the end of surgery to the first administration of rescue analgesic medication will be recorded in minutes. A longer duration indicates a prolonged postoperative analgesic effect. |
From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours
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Total Opioid Consumption During the First 24 Postoperative Hours
기간: During the first 24 hours after surgery
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The total amount of opioid analgesics administered during the first 24 hours after surgery will be recorded. When different opioid agents are used, doses will be converted to intravenous morphine milligram equivalents for comparison between groups. |
During the first 24 hours after surgery
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Requirement for Rescue Analgesia
기간: During the first 24 hours after surgery
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The number and proportion of participants requiring at least one dose of rescue analgesic medication will be compared between the study groups. |
During the first 24 hours after surgery
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Shah HN, Shah RH, Sodha HS, Khandkar AA, Gokhale A. A randomized control trial evaluating efficacy of nephrostomy tract infiltration with bupivacaine after tubeless percutaneous nephrolithotomy. J Endourol. 2012 May;26(5):478-83. doi: 10.1089/end.2011.0465. Epub 2011 Dec 22.
- Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ETIK-2026-28
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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