- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07643883
IPACK vs Adductor Magnus Plane Block Added to Adductor Canal Block for Total Knee Arthroplasty
Comparison of the Effectiveness of IPACK Block Versus Adductor Magnus Muscle Plane Block When Combined With Adductor Canal Block in Total Knee Arthroplasty Surgery
Total knee arthroplasty (TKA) is among the most frequently performed surgical procedures for degenerative joint diseases, including advanced knee osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. More than 700,000 TKA procedures are performed annually in the United States alone since 2012, with projections estimating a 143% increase by 2050. A significant proportion of patients experience moderate to severe postoperative pain following the procedure, adversely affecting early mobilization, adherence to rehabilitation programs, and ultimately functional recovery .
Femoral nerve block (FNB) was historically the cornerstone of TKA analgesia; however, concerns about quadriceps weakness and associated fall risk led to its replacement by more motor-sparing alternatives . Adductor canal block (ACB) has since become the standard approach, providing analgesia equivalent to FNB while significantly preserving quadriceps strength . Nevertheless, ACB does not adequately cover the posterior capsule and popliteal plexus terminals; consequently, 60-80% of TKA patients report significant posterior knee pain that cannot be sufficiently managed by ACB alone .
To address this limitation, several posterior knee analgesia techniques have been described. The IPACK (Interspace between Popliteal Artery and Capsule of the Knee) block targets genicular nerve branches and popliteal plexus terminals by injecting local anesthetic between the popliteal artery and the posterior knee capsule, largely sparing the main motor trunks and providing selective posterior analgesia . The adductor magnus muscle plane (AMM) block is a relatively novel interfascial plane block technique applicable in the supine position simultaneously with ACB. By injecting local anesthetic into the fascial plane along the posterior surface of the adductor magnus muscle, the AMM block aims to spread to the popliteal plexus and posterior capsular branches, potentially mimicking a sciatic nerve block effect . A key advantage of the AMM block is its applicability without patient repositioning during the same session as ACB.
The primary objective of this prospective randomized trial was to compare the effects of IPACK and AMM blocks-both added to ACB-on postoperative opioid consumption in patients undergoing TKA. Secondary objectives included evaluating the impact of each technique on postoperative pain scores, mobilization time, functional recovery, and motor function
연구 개요
상세 설명
Study Design and Ethical Approval This prospective, randomized, parallel-group trial was approved by the Ethics Committee of Atatürk University Faculty of Medicine (Decision No. 5, Meeting No. 7, dated October 26, 2023). Written informed consent was obtained from all participants before enrollment.
Patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III scheduled for primary total knee arthroplasty (TKA) were eligible. Exclusion criteria included hepatic, renal, or advanced cardiac insufficiency; neuropathic pain; use of analgesics within 24 hours before surgery; coagulopathy or anticoagulant therapy; advanced cardiovascular disease; allergy to study medications; inability to cooperate; chronic opioid use; and previous lumbar instrumentation.
Of 90 patients assessed for eligibility, 30 were excluded because of chronic renal failure (n = 3), chronic opioid use (n = 5), anticoagulant therapy (n = 8), inability to cooperate (n = 10), or L2-L4 vertebral instrumentation (n = 4). Sixty patients were included and randomized equally into two groups: IPACK (n = 30) and AMM (n = 30).
Randomization and Blinding Participants were randomized in a 1:1 ratio using a computer-generated randomization sequence one hour before surgery. Allocation assignments were concealed in sealed opaque envelopes and delivered to the operating room technician responsible for preparing the intervention.
The anesthesiologist performing the regional block could not be blinded because of the procedural differences. However, patients, surgeons, and the investigator responsible for postoperative outcome assessment were blinded to group allocation.
Regional Anesthesia Procedures ACB Block All patients received an ultrasound-guided adductor canal block (ACB) combined with either an infiltration between the popliteal artery and capsule of the knee (IPACK) block or an adductor magnus muscle plane (AMM) block.
For the ACB, patients were positioned supine with slight external rotation of the hip. After ultrasound identification of the adductor canal, correct needle placement was confirmed with 2 mL of 0.9% saline, followed by injection of 10 mL of 0.5% bupivacaine diluted with 10 mL of 0.9% saline. Dermatomal sensory assessment was performed 5 minutes after injection.
IPACK Block With the patient supine and the knee slightly externally rotated, the ultrasound transducer was placed transversely on the medial aspect of the distal thigh. After identifying the distal femur and popliteal artery, the needle was advanced in-plane into the interspace between the popliteal artery and femur. Following negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of saline were injected with intermittent aspiration every 5 mL.
AMM Block The transducer was positioned medially over the distal thigh to identify the adductor muscle compartment. The needle was advanced in-plane from anteromedial to posterolateral until a fascial "pop" indicated entry into the posterior compartment. After negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of saline were administered. In the AMM group, the subsequent ACB was performed through needle redirection without a second skin puncture.
For all procedures, needle tip visibility, needle shaft visibility, number of needle insertions, and block performance time were recorded. Dermatomal coverage of the tibial, common peroneal, sural, saphenous, and posterior femoral cutaneous nerves was assessed at 5, 10, 15, 20, 30, and 45 minutes after block placement.
Anesthetic Management Standard monitoring, including electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring, was applied in the operating room. Before spinal anesthesia, patients received intravenous midazolam 2 mg, ondansetron 8 mg, and dexamethasone 8 mg.
Spinal anesthesia was performed under sterile conditions at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle. Following confirmation of cerebrospinal fluid flow, 15 mg hyperbaric bupivacaine was administered intrathecally. Surgery commenced after a sensory block level of T10 was achieved.
Surgical Technique All TKAs were performed under spinal anesthesia using a standard medial parapatellar approach. After exposure of the knee joint, the anterior cruciate ligament and osteophytes were removed, and femoral and tibial bone cuts were performed using standard alignment guides. Trial components were inserted to assess fit, alignment, stability, and range of motion. Final femoral, tibial, and polyethylene components were implanted using a cemented technique with one package of bone cement.
A negative-pressure intra-articular drain was placed before layered wound closure. The procedure concluded with application of a Jones compression bandage.
Perioperative Analgesia Paracetamol 1 g was administered intravenously 30 minutes before completion of surgery and continued every 8 hours postoperatively. Dexketoprofen trometamol 25 mg was administered intraoperatively 30 minutes before the end of surgery and continued every 12 hours postoperatively.
Postoperative analgesia was provided using intravenous patient-controlled analgesia (PCA) with fentanyl (10 µg/mL concentration, 25 µg bolus dose, 15-minute lockout interval, 48-hour duration). In addition, all patients received paracetamol 1 g three times daily and dexketoprofen 25 mg twice daily as part of a multimodal analgesic regimen.
Patients with a visual analog scale (VAS) score ≥ 4 in the recovery room received rescue tramadol 100 mg intravenously. Patients achieving an Aldrete score ≥ 9 were transferred to the ward.
Outcome Measures The primary outcome was postoperative opioid consumption. Secondary outcomes included postoperative pain scores, motor function, mobilization, and functional recovery.
VAS pain scores and adverse events were recorded at 1, 2, 4, 8, 12, 24, and 48 hours postoperatively. Opioid consumption was assessed during the 0-4, 4-8, and 8-24 hour intervals and as a cumulative 24-hour total.
Motor block of the quadriceps femoris and tibialis anterior muscles was evaluated using a three-point scale (0 = paralysis, 1 = paresis, 2 = normal strength) immediately after surgery and at 12, 24, and 48 hours.
Preoperative assessments included walking aid use, presence of varus-valgus deformity, anterior and posterior VAS scores, Timed Up and Go (TUG) test, quadriceps muscle strength, and active range of motion (ROM). The TUG test measured the time required to stand from a chair, walk 3 meters, return, and sit down. Quadriceps strength was assessed isometrically, and active ROM was measured using a goniometer.
On postoperative days 1 and 2, mobilization time, VAS scores, TUG performance, quadriceps strength, ROM, and the Five Times Sit-to-Stand Test (FTSST) were recorded.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Erzurum, 터키 (Türkiye), 25000
- Ataturk University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Anesthesiologists (ASA) physical status I-II-III
- Total Knee Arthroplasty Surgery
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 |
|---|---|
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활성 비교기: ACB+IPACK
Participants in this arm will receive an ultrasound-guided adductor canal block (20 mL of 0.25% bupivacaine) and IPACK block (20 mL of 0.25% bupivacaine) before surgery.
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
|
With the patients in the supine position and the knee slightly externally rotated, the ultrasound transducer will be placed transversely on the medial aspect of the knee, approximately 2-3 cm above the patella. After identifying the distal femoral shaft and the popliteal artery, the needle will be advanced in-plane in an anteromedial direction toward the space between the popliteal artery and the femur. Following negative aspiration and confirmation with normal saline, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be administered, with aspiration performed every 5 mL. Needle tip visibility, needle shaft visibility, number of needle insertions, and block duration will be recorded for all procedures. Dermatomal spread of the tibial, peroneal, sural, saphenous, and posterior femoral cutaneous nerves (PFCN) will be assessed at predefined time points: 5, 10, 15, 20, 30, and 45 minutes after block administration. |
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활성 비교기: ACB+AMM
Adductor Canal + Adductor Magnus Muscle Plane block: Participants in this arm will receive an ultrasound-guided anterior sciatic nerve block (20 mL of 0.25% bupivacaine) and an adductor canal block (20 mL of 0.25% bupivacaine) before surgery.
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.
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With patients supine and the leg slightly abducted and externally rotated, the ultrasound probe will be placed 10-15 cm distal to the inguinal crease and moved medially to visualize the adductor muscles.
The needle will be advanced in-plane from anteromedial to posterolateral, avoiding the femoral vessels and obturator nerve, until a fascial "pop" indicates entry into the posterior compartment.
After negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be injected.
In the AMM group, the adductor canal block will be performed by redirecting the same needle without a second puncture; in the IPACK group, a separate insertion will be used.
Dermatomal spread will be assessed at 5, 10, 15, 20, 30, and 45 minutes after block administration.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Opioid consumption
기간: [Time Frame: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour]
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Postoperative opioid consumption
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[Time Frame: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour]
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Scores (VAS) at Rest and During Movement
기간: [Time Frame: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours,48th hours,]
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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. |
[Time Frame: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours,48th hours,]
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Adverse Effects
기간: [Time Frame: up to 24 hours]
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Opioid-Related Adverse Effects
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[Time Frame: up to 24 hours]
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Evaluation of Nerve Blockade after Nerve Block Application
기간: [Time Frame: 5., 10., 15., 20., 30., and 45. minutes]
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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. |
[Time Frame: 5., 10., 15., 20., 30., and 45. minutes]
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Quadriceps and Anterior Tibialis Muscle Strength
기간: [Time Frame: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours]
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Muscle strength will be assessed using standardized manual muscle testing (paralysis/paresis/normal) for quadriceps and anterior tibialis muscles.
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[Time Frame: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours]
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ahmet Murat Yayık, m_yayik@hotmail.com
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 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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