Hip Joint DisordersNCT03599024
Role of Patient-controlled Epidural Analgesia After Total Hip Replacement
A study testing PCEA, Non-PCEA and Total hip replacement in people with Hip Joint Disorders, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Total hip replacement (THR) is frequently followed by high pain experience. Epidural analgesia is a mainstay in postoperative treatment in patients after THR. The investigators found that patient-controlled epidural analgesia (PCEA) decreases total analgesics consumption compared to conventional method of analgesia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Joint Disorders
- What is being tested?
- PCEA, Non-PCEA and Total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2014to 31 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- ASA I-III on pre-anesthesia evaluation
- ICU admission after total hip replacement surgery
- Glasgow Coma Scale (GCS) 13 or more
- Spontaneous breathing at a rate of 12-24 breaths/min
- SpO2 ≥ 90%
Show all 9Show fewer
- Modified Bromage Score 0 or 1
- Visual analog scale (VAS) ≥ 4
- Signed Informed Consent Form for participation
Who cannot join
- History of long-term opioid therapy (the use of an opioid analgesic at doses higher than codeine 120 mg/day, hydrocodone 40 mg/day, tramadol 200 mg/day or oxycodone 40 mg/day 0-4 days before surgery)
- Indications for revision surgery during immediate postoperative care
- Acute skin disease
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: Patient-controlled Epidural Analgesia Versus Conventional Epidural Analgesia After Total Hip Replacement - a Randomized Trial
Total hip replacement (THR) is frequently followed by high pain experience. Epidural analgesia is a mainstay in postoperative treatment in patients after THR. The investigators found that patient-controlled epidural analgesia (PCEA) decreases total analgesics consumption compared to conventional method of analgesia based on physician's prescription while maintaining similar pain relief and safety profile. Therefore, PCEA should be considered the first choice method of analgesia in patients undergoing THR.
Read the detailed description
The prospective, randomized controlled trial was performed at University Hospital Ostrava. All eligible participants were adult patients of both genders aged 18 years or older, and scheduled for elective orthopaedic surgery (THR). The enrolled patients underwent per-protocol randomization into one of two groups (PCEA or non-PCEA group) using the envelopes method. Randomization was performed immediately after ICU admission by an independent physician, who was not involved in the data collection or management of the study subjects. Following randomization, patients were admitted to the ICU. Data for the analyses were collected for 24 hours after THR. The baseline demographic and preoperative characteristics (age, gender, weight, body mass index, and American Society of Anesthesiologists [ASA] physical status) were obtained at the time of admission. The degree of motor block was assessed using the modified Bromage Score. The level of sedation due to the residual effect of anaesthetics at the time of admission was assessed using a sedation score. The Visual Analogue Scale (VAS) values were determined at hourly intervals and 30 minutes after administration of analgesics to determine the effect of the analgesic dose. The other parameters evaluated at hourly intervals were: a) the presence of hypotension defined as a decrease in systolic blood pressure below 90 mmHg or a greater than 30% decrease from the baseline value; b) bradypnea measured on a numeric scale; c) bradycardia defined as heart rate ≤ 50/min and tachycardia defined as heart rate ≥ 120/min; d) the presence of postoperative nausea and vomiting (PONV); and e) skin itching. At the time of discharge from the ICU, the total consumption of analgesics was recorded, and patients' satisfaction was evaluated using the Likert scale. All patients were perioperatively treated by the protocol for administration of anesthesia and analgesia: The patients were administered 7.5 mg of midazolam orally one hour before surgery. Patients weighing more than 70 kg received 2 mg of bisulepin. Prior to surgery, a subarachnoid blockade was established with 2-4 ml of levobupivacaine 0.5% at the L2-L3 spinal interspace. Subsequently, a catheter for postoperative analgesia was inserted into the epidural space. If the subarachnoid blockade was insufficient for surgery, epidural levobupivacaine 0.5 % was administered to a maximum dose of 10 ml, after which the patient underwent general anesthesia and was excluded from the study. During surgery, patients were sedated with a target-controlled infusion of propofol (dose of 1-2 mg/kg body weight per hour) so that they were asleep but aroused when spoken to. After surgery, patients received a mixture of levobupivacaine 0.1% and sufentanil 1 µg/ml. Postoperatively, patients were moved to the ICU. Immediately after ICU admission, continuous monitoring of vital functions and pain was initiated. When the pain intensity exceeded ≥ 4 points, analgesic therapy was initiated by the administration of a mixture containing levobupivacaine 0.1% and sufentanil 1 μg/ml. The PCEA group was initially given a bolus of 10 ml of the mixture, and then a basal infusion at the rate of 3 ml/h. The bolus was set on 4 ml, a lockout interval of 20 minutes, and a maximum dose of 40 ml/4 h according to the literature recommendation. The non-PCEA group was initially administered 5 ml of the analgesic mixture followed by a basal infusion at 5 ml/h. If pain developed, a bolus of 8 ml of the mixture was administered according to the physician's prescription. If analgesia was insufficient after 1 hour of maximal dosing in both groups, the patient was given adjunctive analgesic therapy including one or a combination of the following drugs: i.v. paracetamol, i.v. metamizole, or i.v. tramadol. Patients requiring systemic adjunctive medication were excluded from the final analysis.
- Conditions
- Hip Joint Disorders
- Being tested
- PCEA, Non-PCEA, Total hip replacement
- Keywords
- patient-controlled analgesia, epidural analgesia, analgesics, drug consumption, total hip replacement, pain relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCEAProcedure or surgery
Also called Patient-controlled epidural analgesia (PCEA)
The patients were able to control the administration of analgesics by themselves.
Non-PCEAProcedure or surgery
Also called Non-patient controlled epidural analgesia (Non-PCEA)
The patients were receiving analgesics according to the physician's prescription.
Total hip replacementProcedure or surgery
All patients enrolled in the study were indicated for total hip replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| PCEA Group | Experimental | The patients randomized into this arm were able to control the administration of analgesics, according to their subjective condition. Receives: Procedure: PCEA; Procedure: Total hip replacement |
| Non-PCEA Group | Active comparator | The patients randomized into this arm were receiving analgesics according to the physician's prescription. Receives: Procedure: Non-PCEA; Procedure: Total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in consumption of analgesics
The primary goal of this prospective, randomized study was to compare the effects of two different sufentanil-based methods of analgesia; patient controlled (PCEA) and conventional non-PCEA) where drug is delivered according to the physician's prescription. The main goal was to determine any difference in total consumption of analgesics.
Measured: 18 months
Secondary outcomes (6)
Patient satisfaction - 24 hours after surgery
Patient satisfaction was assessed using the Likert scale for the period of 24 hours after surgery.
Measured: 24 hours
Degree of pain intensity - 24 hours after surgery
The degree of pain intensity was assessed in patients in both groups. The Visual Analogue Scale (VAS) values were determined at hourly intervals and 30 minutes after administration of analgesics to determine the effect of the analgesic dose. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
Measured: 24 hours
Safety of analgesics administration - hypotension
The safety of the methods of analgesia based on the occurrence of analgesia-related complications measured with the presence of hypotension defined as a decrease in systolic blood pressure below 90 mmHg or a greater than 30% decrease from the baseline value.
Measured: 24 hours
Safety of analgesics administration - bradypnea
The safety of the methods of analgesia based on the occurrence of analgesia-related complications measured with the presence of bradypnea measured on a numeric scale: (1= normal respiratory rate [RR]; 2 = RR ≤ 12/min; and 3 = RR ≤ 8/min)
Measured: 24 hours
Safety of analgesics administration - heart rate abnormalities
The safety of the methods of analgesia based on the occurrence of analgesia-related complications measured with the presence of bradycardia defined as heart rate ≤ 50/min and tachycardia defined as heart rate ≥ 120/min.
Measured: 24 hours
Safety of analgesics administration - PONV
The safety of the methods of analgesia based on the occurrence of analgesia-related complications measured with the presence of PONV as determined using a numerical scale (0 = no nausea; 1 = mild nausea; 2 = antiemetic given; 3 = nausea despite antiemetic; and 4 = vomiting)11; and e) skin itching (yes/no).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2014
- Primary completion1 Dec 2015
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip Joint DisordersStudies 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
- Model description
- The patients were randomized into two groups with two distinct interventions - patient-controlled analgesia vs. conventional analgesia prescribed by the attending physician.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renáta Zoubková, PhDr., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599024
- Sponsor's protocol ID
- FNO-KARIM-07-PCEA
- Other IDs
- MH CZ - DRO-FNOs/2014
- Status last verified
- Jul 2018
- First submitted
- 16 May 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share the individual participant data with other researchers.
Publications
Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007.
PubMed 11929206Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
PubMed 16135349Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
PubMed 17138198Bertini L, Mancini S, Di Benedetto P, Ciaschi A, Martini O, Nava S, Tagariello V. Postoperative analgesia by combined continuous infusion and patient-controlled epidural analgesia (PCEA) following hip replacement: ropivacaine versus bupivacaine. Acta Anaesthesiol Scand. 2001 Jul;45(6):782-5. doi: 10.1034/j.1399-6576.2001.045006782.x.
PubMed 11421841
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Epidural Analgesia Versus Conventional Epidural Analgesia After Total Hip Replacement - a Randomized Trial
- ClinicalTrials.gov ID
- NCT03599024
- Acronym / sponsor ID
- FNO-KARIM-07-PCEA
- Conditions
- Hip Joint Disorders
- Keywords
- patient-controlled analgesia, epidural analgesia, analgesics, drug consumption, total hip replacement, pain relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 26 Jul 2018 (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.
Total hip replacement (THR) is frequently followed by high pain experience. Epidural analgesia is a mainstay in postoperative treatment in patients after THR. The investigators found that patient-controlled epidural analgesia (PCEA) decreases total analgesics consumption compared to conventional method of analgesia based on physician's prescription while maintaining similar pain relief and safety profile. Therefore, PCEA should be considered the first choice method of analgesia in patients undergoing THR.
Detailed description
The prospective, randomized controlled trial was performed at University Hospital Ostrava. All eligible participants were adult patients of both genders aged 18 years or older, and scheduled for elective orthopaedic surgery (THR). The enrolled patients underwent per-protocol randomization into one of two groups (PCEA or non-PCEA group) using the envelopes method. Randomization was performed immediately after ICU admission by an independent physician, who was not involved in the data collection or management of the study subjects. Following randomization, patients were admitted to the ICU. Data for the analyses were collected for 24 hours after THR. The baseline demographic and preoperative characteristics (age, gender, weight, body mass index, and American Society of Anesthesiologists [ASA] physical status) were obtained at the time of admission. The degree of motor block was assessed using the modified Bromage Score. The level of sedation due to the residual effect of anaesthetics at the time of admission was assessed using a sedation score. The Visual Analogue Scale (VAS) values were determined at hourly intervals and 30 minutes after administration of analgesics to determine the effect of the analgesic dose. The other parameters evaluated at hourly intervals were: a) the presence of hypotension defined as a decrease in systolic blood pressure below 90 mmHg or a greater than 30% decrease from the baseline value; b) bradypnea measured on a numeric scale; c) bradycardia defined as heart rate ≤ 50/min and tachycardia defined as heart rate ≥ 120/min; d) the presence of postoperative nausea and vomiting (PONV); and e) skin itching. At the time of discharge from the ICU, the total consumption of analgesics was recorded, and patients' satisfaction was evaluated using the Likert scale. All patients were perioperatively treated by the protocol for administration of anesthesia and analgesia: The patients were administered 7.5 mg of midazolam orally one hour before surgery. Patients weighing more than 70 kg received 2 mg of bisulepin. Prior to surgery, a subarachnoid blockade was established with 2-4 ml of levobupivacaine 0.5% at the L2-L3 spinal interspace. Subsequently, a catheter for postoperative analgesia was inserted into the epidural space. If the subarachnoid blockade was insufficient for surgery, epidural levobupivacaine 0.5 % was administered to a maximum dose of 10 ml, after which the patient underwent general anesthesia and was excluded from the study. During surgery, patients were sedated with a target-controlled infusion of propofol (dose of 1-2 mg/kg body weight per hour) so that they were asleep but aroused when spoken to. After surgery, patients received a mixture of levobupivacaine 0.1% and sufentanil 1 µg/ml. Postoperatively, patients were moved to the ICU. Immediately after ICU admission, continuous monitoring of vital functions and pain was initiated. When the pain intensity exceeded ≥ 4 points, analgesic therapy was initiated by the administration of a mixture containing levobupivacaine 0.1% and sufentanil 1 μg/ml. The PCEA group was initially given a bolus of 10 ml of the mixture, and then a basal infusion at the rate of 3 ml/h. The bolus was set on 4 ml, a lockout interval of 20 minutes, and a maximum dose of 40 ml/4 h according to the literature recommendation. The non-PCEA group was initially administered 5 ml of the analgesic mixture followed by a basal infusion at 5 ml/h. If pain developed, a bolus of 8 ml of the mixture was administered according to the physician's prescription. If analgesia was insufficient after 1 hour of maximal dosing in both groups, the patient was given adjunctive analgesic therapy including one or a combination of the following drugs: i.v. paracetamol, i.v. metamizole, or i.v. tramadol. Patients requiring systemic adjunctive medication were excluded from the final analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients were randomized into two groups with two distinct interventions - patient-controlled analgesia vs. conventional analgesia prescribed by the attending physician.
| Arm | Type | Receives |
|---|---|---|
| PCEA Group | Experimental | Procedure: PCEA, Procedure: Total hip replacementThe patients randomized into this arm were able to control the administration of analgesics, according to their subjective condition. |
| Non-PCEA Group | Active comparator | Procedure: Non-PCEA, Procedure: Total hip replacementThe patients randomized into this arm were receiving analgesics according to the physician's prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- ASA I-III on pre-anesthesia evaluation
- ICU admission after total hip replacement surgery
- Glasgow Coma Scale (GCS) 13 or more
- Spontaneous breathing at a rate of 12-24 breaths/min
Key exclusion criteria (3 listed)
- History of long-term opioid therapy (the use of an opioid analgesic at doses higher than codeine 120 mg/day, hydrocodone 40 mg/day, tramadol 200 mg/day or oxycodone 40 mg/day 0-4 days before surgery)
- Indications for revision surgery during immediate postoperative care
- Acute skin disease
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 |
|---|---|---|
| PCEAAlso: Patient-controlled epidural analgesia (PCEA)The patients were able to control the administration of analgesics by themselves. | Procedure or surgery | PCEA Group |
| Non-PCEAAlso: Non-patient controlled epidural analgesia (Non-PCEA)The patients were receiving analgesics according to the physician's prescription. | Procedure or surgery | Non-PCEA Group |
| Total hip replacementAll patients enrolled in the study were indicated for total hip replacement surgery. | Procedure or surgery | Non-PCEA Group, PCEA Group |
Primary outcome
Difference in consumption of analgesics
Time frame: 18 months
The primary goal of this prospective, randomized study was to compare the effects of two different sufentanil-based methods of analgesia; patient controlled (PCEA) and conventional non-PCEA) where drug is delivered according to the physician's prescription. The main goal was to determine any difference in total consumption of analgesics.
6 secondary outcomes
Patient satisfaction - 24 hours after surgery
Time frame: 24 hours
Degree of pain intensity - 24 hours after surgery
Time frame: 24 hours
Safety of analgesics administration - hypotension
Time frame: 24 hours
Safety of analgesics administration - bradypnea
Time frame: 24 hours
Safety of analgesics administration - heart rate abnormalities
Time frame: 24 hours
Safety of analgesics administration - PONV
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 11929206Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002 Mar-Apr;10(2):117-29. doi: 10.5435/00124635-200203000-00007.
- Background: PubMed 16135349Singelyn FJ, Ferrant T, Malisse MF, Joris D. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous femoral nerve sheath block on rehabilitation after unilateral total-hip arthroplasty. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):452-7. doi: 10.1016/j.rapm.2005.05.008.
- Background: PubMed 17138198Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
- Background: PubMed 11421841Bertini L, Mancini S, Di Benedetto P, Ciaschi A, Martini O, Nava S, Tagariello V. Postoperative analgesia by combined continuous infusion and patient-controlled epidural analgesia (PCEA) following hip replacement: ropivacaine versus bupivacaine. Acta Anaesthesiol Scand. 2001 Jul;45(6):782-5. doi: 10.1034/j.1399-6576.2001.045006782.x.
- Website dealing with post-operative pain management.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators do not plan to share the individual participant data with other researchers.
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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. This study is not recruiting at the moment.
Renáta Zoubková, PhDr. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCEA, Non-PCEA and Total hip replacement in people with Hip Joint Disorders, run by University Hospital Ostrava at 1 site in Czechia.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jul 2018. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in consumption of analgesics (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599024, which also lists 4 linked publications.
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 26 Jul 2018.