Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty
Starting soon · Not applicable
Conditions studied: Total Knee Anthroplasty, Epidural Analgesia
In brief
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
Key facts
- Study ID
- NCT07605208
- Run by
- Sakarya University
- People needed
- 90
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation — Sakarya, Adapazari, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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