- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599024
Role of Patient-controlled Epidural Analgesia After Total Hip Replacement
July 16, 2018 updated by: University Hospital Ostrava
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Moravian-Silesian Region
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Ostrava, Moravian-Silesian Region, Czechia, 708 52
- University Hospital Ostrava
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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%
- Modified Bromage Score 0 or 1
- Visual analog scale (VAS) ≥ 4
- Signed Informed Consent Form for participation
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCEA Group
The patients randomized into this arm were able to control the administration of analgesics, according to their subjective condition.
|
The patients were able to control the administration of analgesics by themselves.
Other Names:
All patients enrolled in the study were indicated for total hip replacement surgery.
|
Active Comparator: Non-PCEA Group
The patients randomized into this arm were receiving analgesics according to the physician's prescription.
|
All patients enrolled in the study were indicated for total hip replacement surgery.
The patients were receiving analgesics according to the physician's prescription.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction - 24 hours after surgery
Time Frame: 24 hours
|
Patient satisfaction was assessed using the Likert scale for the period of 24 hours after surgery.
|
24 hours
|
Degree of pain intensity - 24 hours after surgery
Time Frame: 24 hours
|
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.
|
24 hours
|
Safety of analgesics administration - hypotension
Time Frame: 24 hours
|
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.
|
24 hours
|
Safety of analgesics administration - bradypnea
Time Frame: 24 hours
|
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)
|
24 hours
|
Safety of analgesics administration - heart rate abnormalities
Time Frame: 24 hours
|
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.
|
24 hours
|
Safety of analgesics administration - PONV
Time Frame: 24 hours
|
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).
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Renáta Zoubková, PhDr., University Hospital Ostrava
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Singelyn 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.
- Hartrick 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.
- Bertini 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
March 31, 2016
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
July 16, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 16, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNO-KARIM-07-PCEA
- MH CZ - DRO-FNOs/2014 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators do not plan to share the individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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