- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07595471
Proximal Spread in Adductor Canal Block(ACB) (ACB)
2026년 5월 12일 업데이트: Müge Çakırca, Ankara Etlik City Hospital
The Impact of Injection Level on the Proximal Spread of Local Anesthetic and Clinical Outcomes in Adductor Canal Block
This prospective, randomized clinical study is designed to evaluate the effects of two different injection levels of adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty.
The study will be conducted at Ankara Etlik City Hospital and will include a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
In this study, the comparison will be based on the application of adductor canal block at two distinct injection levels.
In both groups, blocks will be performed under ultrasound (USG) guidance using the same technical principles and standardized conditions; in the first group, the block will be administered at the level where the vasto-adductor membrane is first visualized, while in the second group, it will be performed at the level where the adductor longus ends.
The type, concentration, and volume of local anesthetic used in both groups will be standardized as 20 mL of 0.25% bupivacaine.
The groups will be compared in terms of the proximal spread of the local anesthetic based on the injection level, the area of spread at the apex of the iliopectineal fossa, the involvement of the femoral nerve, the incidence of postoperative falls, and analgesic consumption.
연구 개요
상태
모집하지 않고 적극적으로
상세 설명
This prospective, randomized clinical trial is designed to evaluate the effects of two distinct injection levels of ultrasound-guided adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty (TKA).
The study will be conducted at Ankara Etlik City Hospital with a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
Inclusion and Exclusion Criteria Inclusion criteria are defined as patients aged 18 years and older, with an ASA (American Society of Anesthesiologists) physical status of I-III, scheduled for elective unilateral TKA under spinal anesthesia.
Exclusion criteria include patients scheduled for bilateral knee arthroplasty, known allergy to local anesthetics, chronic pain syndromes or regular opioid use, peripheral neuropathy or neurological diseases affecting femoral nerve function, coagulopathy or use of anticoagulant therapy, infection at the injection site, and patients unable to provide written informed consent.
Randomization and Intervention Patients will be randomized into two groups using the sealed envelope method.
In Group 1, the ACB will be performed under ultrasound (USG) guidance at the level where the vasto-adductor membrane (VAM) is first visualized.
In Group 2, the block will be performed at the level where the adductor longus muscle ends.
All blocks will be administered by experienced anesthesiologists using a standardized dose of 20 mL 0.25% bupivacaine.
Clinicians performing the block will not be involved in the postoperative data collection process.
Procedure and Monitoring All patients will undergo standard monitoring, including electrocardiography (EKG), non-invasive arterial blood pressure, and peripheral oxygen saturation (SpO_2).
Following the administration of spinal anesthesia according to clinical protocols, the ACB will be performed under USG guidance based on the randomization results.
Standard care will be provided throughout the surgical and anesthetic management, and perioperative data will be recorded.
Outcome Measures and Evaluation Following the block, the spread of the local anesthetic will be evaluated in real-time using ultrasound.
The distance between the injection point and the highest proximal point of the anesthetic spread will be measured in centimeters.
Additionally, the spread area of the local anesthetic at the level of the apex of the iliopectineal fossa will be recorded using the planimetric measurement tools of the USG device.
The reach of the local anesthetic to the femoral nerve will also be assessed via USG.
Postoperatively, patients will follow standard clinical monitoring.
Motor block will be evaluated based on the incidence of postoperative falls (yes/no).
Sensory block efficacy will be assessed through total analgesic consumption recorded within the first 24 hours postoperatively.
All collected data will be recorded for statistical analysis and compared based on the injection levels.
연구 유형
중재적
등록 (추정된)
68
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ankara, 터키 (Türkiye), 06000
- Ankara Etlik City Hospital
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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:
* Patients aged > 18 years.
- ASA physical status classification I-III.
- Patients scheduled for elective, unilateral total knee arthroplasty (TKA).
- Planned administration of spinal anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:Scheduled for bilateral knee arthroplasty.
- Known hypersensitivity or allergy to local anesthetics.
- History of chronic pain syndrome or regular opioid consumption.
- Presence of peripheral neuropathy or neurological disorders affecting the femoral nerve.
- Coagulopathy or ongoing anticoagulant therapy.
- Active infection at the site of injection.
- Inability or refusal to provide written informed consent.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Group 1: ACB at the proximal vasto-adductor membrane level (20 mL 0.25% bupivacaine)
Group 1: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the vasto-adductor membrane is first visualized.
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In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the 'Femoral Triangle Block' in current publications,
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활성 비교기: Group 2: Level of the end of the adductor longus
Group 2: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the adductor longus muscle ends.
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In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the true 'Distal Adductor Canal Block' performed in accordance with contemporary anatomical criteria."
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proximal spread of local anesthetic
기간: The first postoperative hour
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The primary objective of this study is to compare the proximal spread of local anesthetic following ultrasound-guided adductor canal block performed at two distinct injection levels.
In the first group, the injection will be administered at the level where the vastoadductor membrane is first visualized ultrasonographically in the proximal region.
In the second group, the injection will be performed at the level where the adductor magnus and sartorius muscles first intersect.In both patient groups, the area of local anesthetic spread at the apex of the iliopectineal fossa will be measured in $cm^2$ using ultrasonography.
Additionally, the distance between the needle insertion point (injection level) and the apex of the iliopectineal fossa, as well as the distance from the needle insertion point to the most proximal point where the local anesthetic is ultrasonographically visualized, will be recorded in cm.
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The first postoperative hour
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Scores (Numeric Rating Scale)
기간: post-op hours 6 and 24
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Evaluation of NRS(Numeric Rating Scale) scores at the 6th and 24th postoperative hours.The Numerical Rating Scale (NRS) is a common subjective clinical tool that requires patients to quantify their pain intensity on a scale ranging from 0 to 10
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post-op hours 6 and 24
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Assessment of Motor Block
기간: Postoperative 24th hours
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Motor block and falls were evaluated at the 24th hour.Ambulation was assessed within the first 24 hours postoperatively.
Successful ambulation was defined as the ability to walk without falling; patients who failed to ambulate or suffered a fall during the attempt were categorized as 'treatment failure'.
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Postoperative 24th hours
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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 (실제)
2026년 4월 7일
기본 완료 (추정된)
2026년 5월 30일
연구 완료 (추정된)
2026년 6월 1일
연구 등록 날짜
최초 제출
2026년 4월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-KAEK-40 (기타 식별자: Ankara Etlik City Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .