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

NCT07605208 | Not Yet Recruiting

• 1 other identifier: SEAH-OTOBOLUS-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Total Knee Anthroplasty; Epidural Analgesia

Keywords

Programmed Intermittent Epidural Bolus; PIEB; Continuous Epidural Infusion; CEI; Patient-Controlled Epidural Analgesia; PCEA; Total Knee Arthroplasty; Postoperative Analgesia; QoR-15

Outcome Measures

Primary Outcomes (1)

• 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.

  From initiation of postoperative epidural analgesia in the post-anesthesia care unit (PACU) to postoperative 24 hours

Secondary Outcomes (5)

• Quality of recovery assessed with QoR-15

  Preoperative baseline and postoperative 24 hours

• Motor block assessed with the modified Bromage scale

  Postoperative 2 and 4 hours

• Number of patient-controlled epidural analgesia bolus demands and delivered boluses

  During the first 24 postoperative hours

• Rescue analgesic consumption

  During the first 24 postoperative hours

• Resting and movement-related pain scores assessed with VAS

  Postoperative 2, 4, 8, 12, and 24 hours

Study Arms (2)

PIEB

EXPERIMENTAL

Participants will receive postoperative epidural analgesia using programmed intermittent epidural bolus (PIEB) combined with patient-controlled epidural analgesia (PCEA). The epidural solution will consist of 0.1% bupivacaine. Automatic epidural boluses of 6 mL will be delivered every 60 minutes. Patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval will also be available.

Procedure: Programmed intermittent epidural bolus 6 ml

CEI

ACTIVE COMPARATOR

Participants will receive postoperative epidural analgesia using continuous epidural infusion (CEI) combined with patient-controlled epidural analgesia (PCEA). The epidural solution will consist of 0.1% bupivacaine. Continuous epidural infusion will be administered at a rate of 6 mL/hour. Patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval will also be available.

Procedure: continuous epidural infusion

Interventions

Programmed intermittent epidural bolus 6 ml PROCEDURE

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.

Also known as: PIEB

PIEB

continuous epidural infusion PROCEDURE

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.

Also known as: CEI

CEI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

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

Sakarya, Adapazari, 54000, Turkey (Türkiye)

Location

Central Study Contacts

Ahmet R Doğan, M.D

CONTACT

+905427988070; a.ridvandogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)