Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty
Comparison of the Effects of iPACK Block Combined With Continuous Adductor Canal Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Total Knee Arthroplasty Cases
This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.
연구 개요
상태
상세 설명
Severe postoperative pain occurs in up to 58% of patients after total knee arthroplasty. Peripheral nerve blocks are an effective component of multimodal analgesia, and the continuous adductor canal block (CACB) has become a preferred technique because it provides sensory blockade while sparing motor function of the quadriceps, allowing earlier ambulation compared to femoral nerve block. However, CACB does not address posterior knee pain, which can be targeted by the iPACK (infiltration between the popliteal artery and capsule of the knee) block, a technique that blocks terminal sensory branches of the tibial and peroneal nerves without motor blockade.
In this study, patients scheduled for total knee arthroplasty will be randomized 1:1 (using randomizer.org) to receive either CACB alone (Group 2) or CACB combined with a single-injection iPACK block (Group 1). CACB will be maintained via a perineural catheter connected to a patient-controlled analgesia (PCA) pump delivering 0.1% bupivacaine. Rescue analgesia will be provided with intravenous tramadol (50 mg, max 300 mg/day) when the numeric rating scale (NRS) pain score exceeds 4.
Pain scores (NRS 0-10), total analgesic and opioid consumption, hemodynamic parameters, time to first mobilization (assessed via the Timed Up and Go test), patient satisfaction, and length of hospital stay will be recorded at baseline and at 1, 3, 6, 12, and 24 hours postoperatively by an anesthesiologist blinded to group allocation, different from the anesthesiologist who performed the block.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muzaffer GENCER, MD
- 전화번호: 905059436459
- 이메일: dr.m.gencer07@gmail.com
연구 연락처 백업
- 이름: Furkan TONTU, MD
- 전화번호: 905465771656
- 이메일: furkantontu@gmail.com
연구 장소
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Istanbul
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Başakşehir, Istanbul, 터키 (Türkiye), 34480
- Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye
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연락하다:
- Muzaffer GENCER, MD
- 전화번호: 905059436459
- 이메일: dr.m.gencer07@gmail.com
-
연락하다:
- Murat Y MERSİN, MD
- 전화번호: 905367736432
- 이메일: myasinmersin@gmail.com
-
수석 연구원:
- Furkan TONTU, MD
-
부수사관:
- Muzaffer GENCER, MD
-
부수사관:
- Murat Y Mersin, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients of either sex
- Aged 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Voluntary participation
- Fully oriented and able to cooperate with postoperative assessments
Exclusion Criteria:
- ASA physical status IV or V
- Patients who decline to participate
- Pediatric patients
- Active infection at the block site
- Chronic pain or regular analgesic use
- Coagulation disorders
- Inability to cooperate with postoperative pain assessment
- Known allergy to local anesthetics
- Neuropathy or myopathy in the operated extremity
- Revision arthroplasty cases
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 |
|---|---|
|
실험적: Group 1 (CACB + iPACK)
Continuous adductor canal block (catheter, PCA with 0.1% bupivacaine) plus a single-injection iPACK block (0.25% bupivacaine 20 mL) |
Single injection of 0.25% bupivacaine 20 mL between the popliteal artery and posterior knee capsule, performed under ultrasound guidance Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
|
활성 비교기: Group 2 (CACB Alone)
Continuous adductor canal block alone (catheter, PCA with 0.1% bupivacaine) |
Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Pain Score (Numeric Rating Scale)
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable) |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Opioid Consumption
기간: Postoperative 24 hours
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Total rescue analgesic (tramadol) consumption via intravenous (IV) administration |
Postoperative 24 hours
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Total Local Anesthetic Consumption
기간: Postoperative 24 hours
|
Total bupivacaine consumed via patient-controlled analgesia (PCA) pump |
Postoperative 24 hours
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|
Time to First Mobilization
기간: Postoperative 24 hours
|
Time to first unassisted ambulation/movement, assessed via the Timed Up and Go (TUG) test |
Postoperative 24 hours
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Length of Hospital Stay
기간: From surgery to discharge (up to approximately 1 week)
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Number of days from surgery to discharge |
From surgery to discharge (up to approximately 1 week)
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Patient Satisfaction Score
기간: Postoperative 24 hours
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Satisfaction rated on a 4-point scale (1 = not satisfied, 2 = Slightly satisfied, 3 = Satisfied, 4 = very satisfied) |
Postoperative 24 hours
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Systolic Blood Pressure
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
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Systolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
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Diastolic Blood Pressure
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
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Diastolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
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Mean Arterial Blood Pressure
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
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Mean arterial blood pressure (MAP) measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
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Heart Rate
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
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Heart rate measured in beats per minute |
Baseline and postoperative hours 1, 3, 6, 12, and 24
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Peripheral Oxygen Saturation
기간: Baseline and postoperative hours 1, 3, 6, 12, and 24
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Peripheral oxygen saturation (SpO2) measured as a percentage |
Baseline and postoperative hours 1, 3, 6, 12, and 24
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Block-Related Complications
기간: Throughout study participation (up to 24 hours postoperatively)
|
Incidence of complications associated with the regional block techniques (e.g., nerve injury, infection) |
Throughout study participation (up to 24 hours postoperatively)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Furkan TONTU, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- 연구 책임자: Muzaffer GENCER, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- 연구 책임자: Murat Y Mersin, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİt
간행물 및 유용한 링크
일반 간행물
- Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
- Diz Protezi Ameliyatı Sonrası Sürekli Adduktör Kanal Bloğuna Popliteal Arter ve Diz Kapsülü Arası İnfiltrasyon Bloğunun (IPACK) Eklenmesinin Etkisi DOI: 10.1080/11101849.2023.2246732
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
기타 연구 ID 번호
- BSH-ANES-MYM-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared beyond what is reported in publications resulting from this study.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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