Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia and Quality of Recovery After Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to compare two different epidural analgesia delivery methods for pain control after total knee arthroplasty in adults undergoing elective surgery. The study will evaluate whether programmed intermittent epidural bolus (PIEB) provides better postoperative analgesia and recovery outcomes than continuous epidural infusion (CEI).
The main questions it aims to answer are:
Does PIEB reduce total epidural local anesthetic consumption during the first 24 postoperative hours compared with CEI? Does PIEB improve postoperative pain control and quality of recovery? Are there differences between the two methods regarding motor block, rescue analgesic requirement, patient-controlled epidural analgesia use, and adverse effects?
Researchers will compare PIEB plus patient-controlled epidural analgesia (PCEA) with CEI plus PCEA in patients undergoing total knee arthroplasty.
Participants will:
Receive combined spinal-epidural anesthesia during surgery Receive postoperative epidural analgesia using either PIEB or CEI Be evaluated for pain scores, motor block, recovery quality, epidural local anesthetic consumption, rescue analgesic requirement, and adverse events during the first 24 postoperative hours
详细描述
Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic procedures and is associated with significant postoperative pain. Inadequate pain control after TKA may delay mobilization, prolong hospitalization, impair rehabilitation, and negatively affect patient satisfaction and recovery quality. Therefore, optimizing postoperative analgesia while minimizing opioid consumption and preserving motor function is an important component of enhanced recovery after surgery (ERAS) protocols.
Epidural analgesia has been widely used for postoperative pain management for decades. Conventional continuous epidural infusion (CEI) provides stable delivery of local anesthetic but may be associated with uneven epidural spread, higher local anesthetic consumption, and increased motor blockade in some patients.
Programmed intermittent epidural bolus (PIEB) is an alternative epidural drug delivery technique in which local anesthetic is administered automatically at predefined intervals as intermittent boluses rather than as a continuous infusion. Due to the higher injection pressure and intermittent delivery pattern, PIEB may improve epidural spread and analgesic quality while reducing total local anesthetic requirements and motor block. Although PIEB has been extensively investigated in obstetric analgesia, evidence regarding its use in major orthopedic surgery remains limited.
This prospective, randomized, double-blind, parallel-group clinical trial aims to compare PIEB plus patient-controlled epidural analgesia (PCEA) with CEI plus PCEA in patients undergoing elective primary total knee arthroplasty under combined spinal-epidural anesthesia.
A total of 90 participants will be enrolled and randomized in a 1:1 ratio into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, clinical care providers, and postoperative outcome assessors will be blinded to group allocation. Epidural analgesia pumps will be covered to conceal the infusion mode. Epidural solution preparation and pump programming will be performed by a separate unblinded investigator who will not participate in postoperative assessments, patient care, or data collection.
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
- 否
入选标准
- •Adults aged 18 to 80 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective primary total knee arthroplasty
- •Eligible for combined spinal-epidural anesthesia and postoperative epidural analgesia
- •Able to understand and use patient-controlled epidural analgesia
- •Provided written informed consent
排除标准
- •Refusal to participate in the study
- •Known allergy or hypersensitivity to study medications
- •Body mass index (BMI) ≥ 40 kg/m²
- •Body weight < 40 kg
- •Severe cardiac disease, including symptomatic arrhythmia or advanced conduction abnormalities
- •Coagulopathy (INR > 1.5 or platelet count < 100,000/mm³)
- •Pregnancy or breastfeeding
- •Revision total knee arthroplasty or emergency surgery
- •Active infection at the site of regional anesthesia
- •Chronic opioid use or opioid dependence
- •Neurological disease or preexisting motor/sensory deficit in the lower extremities
- •ASA physical status IV or V
- •Requirement for intraoperative epidural local anesthetic supplementation due to inadequate spinal anesthesia
研究者
Ayça Taş Tuna
Prof.Dr.
Sakarya University