- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07577869
Biceps Femoris Short Head (BiFeS) Block and Adductor Canal Block for Postoperative Analgesia Following Total Knee Arthroplasty (BiFeS Adductor)
A Comparison of the Effects of Biceps Femoris Short Head Block and Adductor Canal Block in Total Knee Arthroplasty on Postoperative Analgesia Using Multimodal Analgesia Methods
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided Biceps Femoris Short Head (BiFeS) block combined with adductor canal block on postoperative opioid consumption and pain control in patients undergoing elective total knee arthroplasty under spinal anesthesia.
A total of 60 patients aged 18-80 years with ASA physical status I-III scheduled for unilateral elective total knee arthroplasty will be randomized into two groups. The intervention group will receive spinal anesthesia followed by BiFeS block and adductor canal block before surgery, in addition to standard multimodal analgesia and postoperative morphine patient-controlled analgesia (PCA). The control group will receive spinal anesthesia and standard multimodal analgesia with postoperative morphine PCA without peripheral nerve block.
The primary outcome is total morphine consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores assessed by Numeric Rating Scale (NRS), time to first analgesic requirement, time to first foot movement, and Quality of Recovery-15 (QoR-15) scores.
연구 개요
상태
상세 설명
Total knee arthroplasty is associated with significant postoperative pain and high opioid consumption. Peripheral nerve blocks are increasingly used as part of multimodal analgesia strategies to reduce opioid requirements and improve postoperative recovery.
This prospective, randomized, single-center clinical study will be conducted at Kayseri City Hospital Department of Anesthesiology and Reanimation. Sixty adult patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia will be enrolled after written informed consent.
Participants will be randomized into two groups using the closed envelope method.
Intervention Group (n=30):
Patients will receive spinal anesthesia with 3.5-4 mL 0.5% hyperbaric bupivacaine. Before surgical incision, ultrasound-guided BiFeS block will be performed using 25 mL of 0.25% bupivacaine, followed by ultrasound-guided adductor canal block using 15 mL of 0.25% bupivacaine.
Control Group (n=30):
Patients will receive spinal anesthesia only without peripheral nerve block.
All patients will receive standard multimodal analgesia including intravenous paracetamol 1 g every 8 hours and intravenous dexketoprofen 50 mg every 12 hours. Postoperative analgesia will be provided using morphine PCA prepared as 1 mg/mL concentration with 15-minute lockout interval and maximum 4 boluses per hour.
Rescue analgesia will be administered as intravenous fentanyl 25 mcg in patients with NRS score ≥4 despite PCA use.
Primary outcome measure is total morphine consumption during the first 24 postoperative hours.
Secondary outcome measures include Numeric Rating Scale pain scores at postoperative 1, 6, 12, and 24 hours, time to first analgesic requirement, time to first active foot movement, rescue analgesic requirement, and postoperative Quality of Recovery-15 scores.
The study hypothesis is that combined BiFeS and adductor canal block will reduce postoperative opioid consumption and improve recovery quality compared with standard multimodal analgesia alone.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Omer Kayar, Medicinae Doctor
- 전화번호: +90 531 578 90 37
- 이메일: dr.omer.kayar@hotmail.com
연구 장소
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Kocasinan
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Kayseri, Kocasinan, 터키 (Türkiye), 38080
- Kayseri City Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 and older
- ASA I-III
- Patients scheduled for elective unilateral knee replacement
- Eligibility for and consent to spinal anesthesia
Exclusion Criteria:
- History of allergy or anaphylaxis to local anesthetics, animal gelatin, or chlorhexidine
- Bleeding diathesis/inability to discontinue anticoagulants
- Infection (at the injection site/sepsis)
- Neurological disorders or cognitive impairment affecting pain perception
- Pregnancy, breastfeeding
- Patients under 18 years of age
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Block Group
Patients receive spinal anesthesia followed by ultrasound-guided BiFeS block and adductor canal block before surgery, plus standard multimodal analgesia and morphine PCA.
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Patients will receive spinal anesthesia followed by ultrasound-guided Biceps Femoris Short Head (BiFeS) block using 25 mL of 0.25% bupivacaine and adductor canal block using 15 mL of 0.25% bupivacaine before surgery.
Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.
다른 이름들:
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활성 비교기: Multimodal Analgesia Group
Patients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA.
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Patients will receive spinal anesthesia without peripheral nerve block.
Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Morphine Consumption in 24 Hours
기간: Within the first 24 hours after surgery
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Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.
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Within the first 24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric Rating Scale (NRS) Pain Scores
기간: Postoperative 1, 6, 12, and 24 hours
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Pain intensity measured using NRS at rest (0-10 scale).
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Postoperative 1, 6, 12, and 24 hours
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Time to First Analgesic Requirement
기간: 24 hours
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Time from end of surgery to first patient-reported pain requiring analgesic medication.
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24 hours
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Time to First Foot Movement
기간: 24 hours
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Time from completion of surgery to first active foot movement.
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24 hours
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QoR-15 Score
기간: 24 hours postoperatively
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Postoperative quality of recovery will be assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15), which evaluates patient well-being, physical comfort, emotional state, psychological support, and pain.
Total scores range from 0 to 150, with higher scores indicating better postoperative recovery.
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24 hours postoperatively
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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
추가 관련 MeSH 약관
기타 연구 ID 번호
- KSH-ANES-2026/77
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
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. .
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