Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
NCT06878014 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-02-12
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.
Conditions
- Analgesics, Opioid
- Anesthesia, Spinal
- Total Hip Replacement
- Adverse Anesthesia Outcome
Interventions
- PROCEDURE
-
Spinal 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).
- DRUG
-
Postoperative pain management with acetaminophen
Postoperatively patients received 1,0g of paracetamol every 6 hours,
- DEVICE
-
PCA 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.
- DRUG
-
Postoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
- DRUG
-
Postoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
- DRUG
-
Preemptive Analgesics
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
- DEVICE
-
Patient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
Sponsors & Collaborators
-
Medical University of Silesia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-04
- Primary Completion
- 2026-06-28
- Completion
- 2026-06-28
Countries
- Poland
Study Locations
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