Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty

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:

* PIEB + PCEA group * CEI + PCEA group

Randomization will be performed using a computer-generated randomization sequence with allocation concealment through sequentially numbered opaque sealed envelopes.

All participants will receive standardized combined spinal-epidural anesthesia. Epidural catheter placement will be performed at the L2-L3 interspace using the needle-through-needle technique. Spinal anesthesia will be achieved with 12.5 mg hyperbaric bupivacaine administered intrathecally.

Postoperatively, all participants will receive epidural analgesia using the same epidural solution consisting of 0.1% bupivacaine diluted in normal saline.

In the PIEB group, epidural analgesia will be delivered as programmed intermittent epidural boluses of 6 mL every 60 minutes combined with patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval.

In the CEI group, epidural analgesia will be delivered as continuous epidural infusion at 6 mL/hour combined with patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval.

All participants will additionally receive standardized multimodal analgesia with scheduled paracetamol administration. Intravenous tramadol will be used as rescue analgesia when the visual analog scale (VAS) pain score is 4 or greater.

The primary outcome measure is total epidural local anesthetic consumption during the first 24 postoperative hours.

Secondary outcome measures include:

* Quality of recovery assessed using the QoR-15 questionnaire * Motor block assessed with the modified Bromage scale * Number of patient-controlled epidural bolus demands and delivered boluses * Rescue analgesic consumption * Resting and movement-related VAS pain scores

Pain scores will be assessed at postoperative 2, 4, 8, 12, and 24 hours. QoR-15 will be evaluated preoperatively and at postoperative 24 hours.

The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent will be obtained from all participants before enrollment.

• Quality of recovery assessed with QoR-15 [Срок оценки: Preoperative baseline and postoperative 24 hours]
• Motor block assessed with the modified Bromage scale [Срок оценки: Postoperative 2 and 4 hours]
• Number of patient-controlled epidural analgesia bolus demands and delivered boluses [Срок оценки: During the first 24 postoperative hours]
• Rescue analgesic consumption [Срок оценки: During the first 24 postoperative hours]
• Resting and movement-related pain scores assessed with VAS [Срок оценки: Postoperative 2, 4, 8, 12, and 24 hours]