Clinical trial NCT03599024: Role of Patient-controlled Epidural Analgesia After Total Hip Replacement
Official title: Patient-controlled Epidural Analgesia Versus Conventional Epidural Analgesia After Total Hip Replacement - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Joint Disorders
Keywords: patient-controlled analgesia
epidural analgesia
analgesics
drug consumption
total hip replacement
pain relief
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomized into two groups with two distinct interventions - patient-controlled analgesia vs. conventional analgesia prescribed by the attending physician.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in consumption of analgesics
timeFrame: 18 months
Secondary outcomes:
measure: Patient satisfaction - 24 hours after surgery
timeFrame: 24 hours
measure: Degree of pain intensity - 24 hours after surgery
timeFrame: 24 hours
measure: Safety of analgesics administration - hypotension
timeFrame: 24 hours
measure: Safety of analgesics administration - bradypnea
timeFrame: 24 hours
measure: Safety of analgesics administration - heart rate abnormalities
timeFrame: 24 hours
measure: Safety of analgesics administration - PONV
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Renáta Zoubková, PhDr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.