Analgesics, Opioid, Anesthesia, Spinal, Total Hip Replacement, Adverse Anesthesia Outcome
Conditions
Brief summary
Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression. To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks. The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.
Interventions
PROCEDURESpinal Anesthesia (bupivacaine)
Patients were positioned in sitting position on operating table, interspinous space was identified using anatomical landmarks (intercristal line) and palpation. Entire procedure was conducted with aseptic technique, puncture site was prepared with izopropyl alcohol solution. Skin was anesthetized with subcutaneous injection of 1% lidocaine. Spinal puncture was achieved using median or paramedian technique with 27G pencil-point spinal needle. After confirmation of free flow of cerebrospinal fluid 15 mg of 0,5% bupivacaine was administered intrathecaly. Block level was assessed by lack of sensation to alcohol swab in periumbilical area and complete motor block (Bromage 3).
Postoperatively patients received 1,0g of paracetamol every 6 hours,
DEVICEPCA IV Oxycodone
All patients were equipped with PCA capable syringe pump (Perfusor Space, B. Braun) with 40 milligrams of oxycodone. Care provider explained thoroughly how to operate the device and educated about possible adverse effects.
DRUGPostoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
DRUGPostoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
DEVICEPatient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent to participate in trial * Qualification for total hip replacement surgery * ASA physical status I-III * BMI 19-30 * Lack of contraindications for drugs and interventions used in trial
Exclusion criteria
* Incapability to provide informed consent * Contraindications for spinal anesthesia * Preoperative chronic pain * Chronic use of analgesics * Obesity (BMI\>30) * Allergies and other contraindications for drugs used in trial * Mental or physical incapability to operate PCA syringe pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy | 48 hours postoperatively | Analgesic efficacy defined as mean value of NRS (Numerical Rating Scale) at 4, 8, 12 ,24 and 48 hours postoperatively at rest and during rehabilitation/movement. |
| Safety profile | 48 hours postoperatively | Frequency of adverse events including excessive sedation (defined as Richmond Agitation Sedation Score RASS≤-1), constipation, postoperative nausea and vomiting, pruritus and respiratory depression defined as sudden drop in respiration rate by ≥90% for ≥10 seconds or cyanosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 48 hours postoperatively | Patient satisfaction with pain management measured with Likert scale. 1. Very satisfied. 2. Satisfied. 3. Neither satisfied nor dissatisfied. 4. Dissatisfied. 5. Very dissatisfied. |
| Length of stay | Up to one week. | Length of stay postoperatively. |
| Time to rescue analgesia | 48 hours postoperatively | Amount of time before first bolus of oxycodone delivered by PCA syringe pump. |
| Cumulative dose of oxycodone | 48 hours postoperatively | Cumulative dose of oxycodone over 48 hours postoperatively. |
Countries
Poland
Contacts
CONTACTSzymon Białka, MD PhD
CONTACTJakub Żak, MD
Outcome results
None listed