Comparative Evaluation of Biceps Femoris Short Head (BiFeS) and Adductor Canal Block and Interspace Between the Popliteal Artery and Capsule of the Knee (IPACK) and Adductor Canal Block Combinations for Postoperative Pain After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption in the first 24 hours after surgery
研究概览
简要总结
This prospective observational study will compare the postoperative analgesic efficacy of two multimodal regional anesthesia combinations routinely used after total knee arthroplasty (TKA) performed under spinal anesthesia. The study will observe patient groups who receive, as part of standard clinical practice, either the Biceps Femoris Short Head (BiFeS) block combined with the Adductor Canal Block (ACB) or the Interspace Between the Popliteal Artery and the Capsule of the Knee (IPACK) block combined with the Adductor Canal Block (ACB). The research team will not assign, perform, or direct any blocks; all regional anesthesia procedures will be administered independently by anesthesiologists experienced in ultrasound-guided regional anesthesia as part of routine care.
Postoperative pain will be observed and documented using the Numeric Rating Scale (NRS) at multiple time points within the first 24 hours. Opioid consumption will be recorded based on intravenous patient-controlled analgesia (PCA) data, and the need for rescue analgesia will be noted. Additional postoperative observations will include functional recovery, quality of recovery scores, and the incidence of adverse events.
Postoperative pain will be evaluated using the Numeric Rating Scale (NRS) at multiple time points within the first 24 hours. Opioid consumption will be recorded through intravenous patient-controlled analgesia (PCA), and the need for rescue analgesia will be assessed. Additional postoperative observations will include functional recovery, quality of recovery scores, and the incidence of adverse events.
详细描述
This prospective, single-center, observational study will be conducted at Karabük Training and Research Hospital. This is an observational study. Participants are not assigned to any intervention by the research team. All regional anesthesia blocks are performed as part of routine clinical practice, and the investigators only collect data related to outcomes. No interventions are administered because of study participation. The research team does not perform, modify, or direct any clinical procedures; all blocks are performed independently as part of routine care.
The study population will include adults aged 18-80 years undergoing elective unilateral total knee arthroplasty (TKA) under spinal anesthesia. All eligible patients will receive routine multimodal analgesia and will undergo one of two commonly used regional anesthesia combinations:
Biceps Femoris Short Head (BiFeS) block + Adductor Canal Block (ACB)
Interspace Between the Popliteal Artery and the Capsule of the Knee (IPACK) block + Adductor Canal Block (ACB)
The choice of block combination will be determined by the attending anesthesiologist as part of standard clinical practice. The research team will not influence clinical decisions and will only record perioperative and postoperative data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-80 years scheduled for elective unilateral total knee arthroplasty (TKA) under spinal anesthesia
- •ASA physical status I-III
- •Eligible for and capable of using patient-controlled analgesia (PCA)
- •Provided written informed consent
排除标准
- •Chronic opioid use for more than four weeks before surgery
- •Presence of chronic pain conditions (e.g., migraine, fibromyalgia)
- •History of alcohol or drug abuse
- •Known allergy or hypersensitivity to local anesthetics or opioids
- •Severe organ dysfunction (e.g., significant hepatic or renal disease)
- •Revision or bilateral knee arthroplasty
- •Contraindications to regional anesthesia
- •Preexisting neuropathy or prior femoral vascular surgery on the operated side.
- •Infection near the injection site (e.g., osteomyelitis, septic joint).
- •Contraindication to spinal anesthesia (e.g., refusal, coagulopathy, use of anticoagulants or antiplatelet agents) or inability to understand NRS.
- •Severe psychiatric or cognitive disorders (e.g., psychosis, dementia) that prevent cooperation or pain assessment
- •Pregnant or breastfeeding women
研究组 & 干预措施
Group BiFeS
Adductor canal block and BiFeS block ( 15 ml %0.25 bupivacaine and 25 ml %0.25 bupivacaine) + IV morphine patient-controlled analgesia (PCA)
Group IPACK
Adductor canal block and IPACK block ( 15 ml %0.25 bupivacaine and 25 ml %0.25 bupivacaine) + IV morphine patient-controlled analgesia (PCA)
结局指标
主要结局
Cumulative opioid consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.
次要结局
- Length of hospital stay(From surgery to postoperative day 2-4)
- Cumulative opioid consumption in the first 12 hours after surgery(postoperative 12th hour)
- Postoperative pain scores(Postoperative day 1)
- Block performance time(İntraoperative period)
- The Quality of Recovery-15 (QoR-15) score(24 hours postoperatively and postoperative day 2-4)
- The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication(Postoperative day 1)
- Time of first analgesic request(Postoperative day 1)
- Number of patients requiring rescue analgesia(Postoperative day 1)
- Block-related complications(Postoperative day 7)
- Opioid-related side effects(Postoperative day 7)
- Timed Up and Go (TUG) test duration(Postoperative day 1)
- Time to first mobilization(Postoperative day 1 and postoperative day 2-4)
研究者
Elif Sarikaya Ozel
Anesthesiologist, Principal Investigator
Karabuk University