NCT06878014

Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery

Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-06-28
• Completion: 2026-06-28
• First posted: 2025-03-14
• Last updated: 2026-02-12

Locations

3 sites across 1 country: Poland