Total Knee AnthroplastyNCT07605208
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty
A study testing Programmed intermittent epidural bolus 6 ml and continuous epidural infusion in people with Total Knee Anthroplasty and Epidural Analgesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Anthroplasty, Epidural Analgesia
- What is being tested?
- Programmed intermittent epidural bolus 6 ml and continuous epidural infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Adapazari, 54000
AHMET R DOĞAN, M.D, +905427988070, a.ridvandogan@gmail.com
About this study
Official title: Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia and Quality of Recovery After Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial
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:
Read more
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
Read the detailed description
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.
- Conditions
- Total Knee Anthroplasty, Epidural Analgesia
- Being tested
- Programmed intermittent epidural bolus 6 ml, continuous epidural infusion
- Keywords
- Programmed Intermittent Epidural Bolus, PIEB, Continuous Epidural Infusion, CEI, Patient-Controlled Epidural Analgesia, PCEA, Total Knee Arthroplasty, Postoperative Analgesia, QoR-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed intermittent epidural bolus 6 mlProcedure or surgery
Also called PIEB
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 infusionProcedure or surgery
Also called CEI
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Preoperative baseline and postoperative 24 hours
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.
Measured: Postoperative 2 and 4 hours
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.
Measured: During the first 24 postoperative hours
Rescue analgesic consumption
Rescue analgesic consumption will be assessed as the total amount of intravenous tramadol administered for breakthrough pain requiring rescue analgesia.
Measured: During the first 24 postoperative hours
Resting and movement-related pain scores assessed with VAS
Postoperative pain intensity at rest and during movement will be assessed using a 10-point visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Postoperative 2, 4, 8, 12, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Taş Tuna, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605208
- Sponsor's protocol ID
- SEAH-OTOBOLUS-2026
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not yet been determined. De-identified data may be shared upon reasonable request following publication of the study results, subject to institutional and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia and Quality of Recovery After Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07605208
- Acronym / sponsor ID
- SEAH-OTOBOLUS-2026
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIEB | Experimental | Procedure: Programmed intermittent epidural bolus 6 mlParticipants 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. |
| CEI | Active comparator | Procedure: continuous epidural infusionParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed intermittent epidural bolus 6 mlAlso: PIEBPostoperative 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. | Procedure or surgery | PIEB |
| continuous epidural infusionAlso: CEIPostoperative 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. | Procedure or surgery | CEI |
Primary outcome
Total epidural local anesthetic consumption during the first 24 postoperative hours
Time frame: 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.
5 secondary outcomes
Quality of recovery assessed with QoR-15
Time frame: Preoperative baseline and postoperative 24 hours
Motor block assessed with the modified Bromage scale
Time frame: Postoperative 2 and 4 hours
Number of patient-controlled epidural analgesia bolus demands and delivered boluses
Time frame: During the first 24 postoperative hours
Rescue analgesic consumption
Time frame: During the first 24 postoperative hours
Resting and movement-related pain scores assessed with VAS
Time frame: Postoperative 2, 4, 8, 12, and 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not yet been determined. De-identified data may be shared upon reasonable request following publication of the study results, subject to institutional and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed intermittent epidural bolus 6 ml and continuous epidural infusion in people with Total Knee Anthroplasty and Epidural Analgesia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet R Doğan, M.D (+905427988070, a.ridvandogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total epidural local anesthetic consumption during the first 24 postoperative hours (time frame: From initiation of postoperative epidural analgesia in the post-anesthesia care unit (PACU) to postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.