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
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
Refusal to participate in the study
Known allergy or hypersensitivity to study medications
Body mass index (BMI) ≥ 40 kg/m²
Body weight < 40 kg
Parallel
Programmed intermittent epidural bolus 6 ml
Procedure/SurgeryPostoperative 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
Procedure/SurgeryPostoperative 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.
Total epidural local anesthetic consumption during the first 24 postoperative 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.
Quality of recovery assessed with QoR-15
Postoperative recovery quality will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 is a validated 15-item patient-reported outcome measure with total scores ranging from 0 to 150, where higher scores indicate better recovery.
Motor block assessed with the modified Bromage scale
Motor block severity will be evaluated using the modified Bromage scale, ranging from 0 to 3, where 0 indicates no motor block and 3 indicates complete motor block. Higher scores indicate greater motor blockade. Motor block presence will additionally be defined as a Bromage score of 1 or greater.
Number of patient-controlled epidural analgesia bolus demands and delivered boluses
The total number of patient-controlled epidural analgesia (PCEA) bolus demands and successfully delivered boluses will be recorded using epidural pump data.
Rescue analgesic consumption
Rescue analgesic consumption will be assessed as the total amount of intravenous tramadol administered for breakthrough pain requiring rescue analgesia.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
