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Clinical Trials in Turkey / NCT07605208
Starting soon Not applicable

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

NCT07605208 · tracked via the Priya Life Science Turkey tracker
Sponsor
Sakarya University
Phase
Not applicable
Started
2026-06-01
Last updated
2026-05-28

Condition(s) studied

Total Knee AnthroplastyEpidural Analgesia

Investigational drug(s) / intervention(s)

Programmed intermittent epidural bolus 6 mlcontinuous epidural infusion

Programmed intermittent epidural bolus 6 ml: Postoperative epidural analgesia delivered as programmed intermittent epidural boluses using 0.1% bupivacaine. Automatic boluses of 6 mL will be administered every 60 minutes in combination with patient-controlled epidural analgesia boluses of 6 mL with a 30-minute lockout interval.

continuous epidural infusion: Postoperative epidural analgesia delivered as continuous epidural infusion using 0.1% bupivacaine at a rate of 6 mL/hour in combination with patient-controlled epidural analgesia boluses of 6 mL with a 30-minute lockout interval.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Total epidural local anesthetic consumption during the first 24 postoperative hours — From initiation of postoperative epidural analgesia in the post-anesthesia care unit (PACU) to postoperative 24 hours
    Total epidural local anesthetic consumption will be calculated as the sum of automatic epidural boluses and patient-controlled epidural analgesia boluses delivered during the first 24 postoperative hours. Total consumption will be recorded in milliliters (mL) using epidural pump records.

Trial sites (1)

FacilityCityRegionStatus
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation Sakarya Adapazari

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Other trials for the same condition

"The Effect of AI-Assisted Mobilization Education on Kinesiophobia and Readiness for Hospital Discharge in Patients Undergoing Total Knee Arthroplasty'' Recruiting
Effect of Combined Adductor Canal and AFCN Block on Postoperative Inflammation Active, not recruiting
Proximal Spread in Adductor Canal Block(ACB) Active, not recruiting
Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07605208 on ClinicalTrials.gov ↗ ← All trials in Turkey