Comparison of Anterior Sciatic Nerve Block and Adductor Magnus Muscle Plane Block for Anterior Cruciate Ligament Surgery
Comparison of Anterior Sciatic Nerve Block and Adductor Magnus Muscle Plane Block Added to Adductor Canal Block in Patients Undergoing Anterior Cruciate Ligament Surgery
연구 개요
상태
상세 설명
This single-center, prospective, randomized clinical trial included 90 patients aged 18-45 years with ASA physical status I-II who underwent arthroscopic anterior cruciate ligament reconstruction under spinal anesthesia. Patients were randomly allocated into three groups to receive either adductor canal block alone (Group C), adductor canal block combined with anterior sciatic nerve block (Group ASB), or adductor canal block combined with adductor magnus muscle plane block (Group AMB). Randomization was performed using a computer-generated sequence with concealed allocation through sealed opaque envelopes. Although the anesthesiologist performing the blocks was aware of group allocation, all postoperative assessments were conducted by an independent blinded investigator. All regional blocks were ultrasound-guided and performed preoperatively by the same experienced anesthesiologist using standardized techniques and local anesthetic volumes. Procedural characteristics, including block performance time, needle visibility, needle passes, and sonographic visibility of target structures, were systematically recorded. Sensory blockade was assessed at predefined intervals using cold-warm discrimination tests across multiple nerve distributions.
All patients received standardized spinal anesthesia with hyperbaric bupivacaine, as well as a multimodal postoperative analgesic regimen including intravenous paracetamol, dexketoprofen, and fentanyl-based patient-controlled analgesia. Postoperative pain scores at rest and during movement were evaluated at multiple time points during the first 24 hours, while cumulative fentanyl consumption, time to first PCA demand, and rescue analgesic requirements were recorded. Opioid-related adverse events, including nausea, vomiting, constipation, pruritus, dry mouth, and urinary retention, were also documented. In addition, postoperative motor function of the tibialis anterior and quadriceps femoris muscles was assessed using a three-point qualitative motor scale at predefined postoperative intervals up to 48 hours.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Erzurum, 터키 (Türkiye), 25100
- Ataturk Universtiy
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Anesthesiologists (ASA) physical status I-II,
- Scheduled for arthroscopic anterior cruciate ligament reconstruction
Exclusion Criteria:
- cardiovascular disease,
- hepatic dysfunction,
- coagulopathy or current use of anticoagulant therapy,
- inability to cooperate,
- known allergy to any of the study medications,
- refusal to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Adductor Canal Block
Participants in this arm will receive an ultrasound-guided adductor canal block using 20 mL of 0.25% bupivacaine.
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
다른 이름들:
|
|
활성 비교기: Adductor Canal + Anterior Sciatic nerve block
Participants in this arm will receive an ultrasound-guided anterior sciatic nerve block (20 mL of 0.25% bupivacaine) and adductor canal block (20 mL of 0.25% bupivacaine).
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
다른 이름들:
An ultrasound transducer was placed perpendicular to the anterior thigh.
The sartorius muscle, femoral artery and vein, adductor longus muscle, adductor magnus muscle, and the sciatic nerve were identified.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced toward the sciatic nerve under ultrasound guidance.
Nerve stimulation was applied, and an appropriate motor response in the sciatic nerve distribution was obtained at 0.2-0.5 mA.
After injection of 2 mL of 0.9% saline and visualization of perineural spread to confirm correct needle placement, 20 mL of 0.25% bupivacaine was administered.
다른 이름들:
|
|
활성 비교기: Adductor Canal + Adductor magnus plane block
Participants in this arm will receive an ultrasound-guided adductor magnus plane block (20 mL of 0.25% bupivacaine) and an adductor canal block (20 mL of 0.25% bupivacaine).
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
다른 이름들:
An ultrasound transducer was placed perpendicular to the thigh to visualise the sartorius muscle, femoral artery and vein, adductor longus, and the underlying adductor magnus muscle.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced until the posterior fascia of the adductor magnus muscle was penetrated.
After injection of 2 mL of 0.9% NaCl solution, correct needle placement was confirmed by observing fluid spread beneath the posterior surface of the adductor magnus muscle.
Subsequently, 20 mL of 0.25% bupivacaine was administered.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Opioid consumption
기간: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour
|
Postoperative opioid consumption
|
0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Scores (VAS) at Rest and During Movement
기간: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours
|
Pain intensity will be evaluated using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).
Assessments will be performed at rest and during movement at predefined postoperative time points.
|
PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours
|
|
Adverse Effects
기간: up to 24 hours
|
Opioid-Related Adverse Effects
|
up to 24 hours
|
|
Evaluation of Nerve Blockade after Nerve Block Application
기간: 5., 10., 15., 20., 30., and 45. minutes
|
Post-block sensory assessment was performed at predefined time intervals using a cold-warm discrimination test. Sensory evaluation was conducted at the plantar surface of the foot for the tibial nerve, the dorsal surface of the foot for the superficial peroneal nerve, the posterolateral aspect of the leg for the sural nerve, the posterior aspect of the thigh for the posterior femoral cutaneous nerve, and at the medial malleolus for the saphenous nerve. |
5., 10., 15., 20., 30., and 45. minutes
|
|
Quadriceps and Anterior Tibialis Muscle Strength
기간: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours
|
Muscle strength will be assessed using standardized manual muscle testing (paralysis/paresis/normal) for quadriceps and anterior tibialis muscles.
|
4th hours, 8th hours, 12th hours, 24th hours, 48th hours
|
공동 작업자 및 조사자
수사관
- 연구 의자: Samet Kapakin, Professor, Atatürk University
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
- B.30.2.ATA.0.01.00/761
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. .
Adductor canal block에 대한 임상 시험
-
Wayne State University완전한
-
Wayne State University모병오피오이드 사용 | 수술 후 통증, 급성미국
-
Ain Shams University아직 모집하지 않음기능 회복 | 내전관 블록 | 슬관절 전치환술
-
University of Chicago완전한
-
Bakirkoy Dr. Sadi Konuk Research and Training Hospital완전한