Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
| Registry | NCT06878014 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Medical University of Silesia (Other) |
| Conditions | Analgesics, Opioid, Anesthesia, Spinal, Total Hip Replacement, Adverse Anesthesia Outcome |
| Interventions | Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen, PCA IV Oxycodone, Postoperative pain management with dexketoprofen, Postoperative pain management with metamizole, Preemptive Analgesics, Patient monitor (Procedure, drug, device) |
| Dates | start 2025-03-04, primary completion 2026-06-28 (estimated), completion 2026-06-28 (estimated), first posted 2025-03-14, last updated 2026-02-12 |
| Locations | 3 sites in Poland |
Related Papers Related Patents Related Grants Related Experts
All trials for Analgesics, Opioid All trials for Anesthesia, Spinal All trials of Spinal Anesthesia (bupivacaine) All trials of Postoperative pain management with acetaminophen
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| M50 | Active comparator | Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor | In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly. |
| M100 | Active comparator | Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor | In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly. |
| M150 | Active comparator | Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor | In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly. |
Sex: All, ages: 18 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary | Sosnowiec, Silesian Voivodeship | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie | Szczecin, West Pomeranian Voivodeship | Poland | Not yet recruiting |
| Zespół Opieki Zdrowotnej w Końskich | Gmina Końskie, Świętokrzyskie Voivodeship | Poland | Recruiting |