Analgesics, OpioidPhase 4NCT06878014
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
A Phase 4 study testing Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen and PCA IV Oxycodone in people with Analgesics, Opioid and Anesthesia, Spinal, run by Medical University of Silesia at 3 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesics, Opioid, Anesthesia, Spinal, Total Hip Replacement
- What is being tested?
- Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen and PCA IV Oxycodone
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesPoland
- Study dates
- 4 Mar 2025to 28 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites, 3 recruiting
- Recruiting
Zespół Opieki Zdrowotnej w Końskich
Gmina Końskie, Świętokrzyskie Voivodeship, 26-200
Wojciech Gola, MD PhD, +48504606247, golawojtek@gmail.com
Wojciech Gola, MD PhD
- Recruiting
Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary
Sosnowiec, Silesian Voivodeship, 41-214
Jakub Żak, MD, +48607936667, jakubzak.sum@gmail.com
Jakub Żak, MD
- Not yet recruiting
Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie
Szczecin, West Pomeranian Voivodeship, 70-204
About this study
Official title: Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
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.
- Being tested
- Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen, PCA IV Oxycodone, Postoperative pain management with dexketoprofen, Postoperative pain management with metamizole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia (bupivacaine)Procedure or surgery
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).
Postoperative pain management with acetaminophenDrug
Postoperatively patients received 1,0g of paracetamol every 6 hours,
PCA IV OxycodoneDevice
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.
Postoperative pain management with dexketoprofenDrug
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
Postoperative pain management with metamizoleDrug
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
Preemptive AnalgesicsDrug
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
Patient monitorDevice
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| M50 | Active comparator | In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly. Receives: 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 |
| M100 | Active comparator | In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly. Receives: 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 |
| M150 | Active comparator | In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy
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.
Measured: 48 hours postoperatively
Safety profile
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.
Measured: 48 hours postoperatively
Secondary outcomes (4)
Patient satisfaction
Patient satisfaction with pain management measured with Likert scale.
- Very satisfied.
- Satisfied.
- Neither satisfied nor dissatisfied.
- Dissatisfied.
- Very dissatisfied.
Measured: 48 hours postoperatively
Length of stay
Length of stay postoperatively.
Measured: Up to one week.
Time to rescue analgesia
Amount of time before first bolus of oxycodone delivered by PCA syringe pump.
Measured: 48 hours postoperatively
Cumulative dose of oxycodone
Cumulative dose of oxycodone over 48 hours postoperatively.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start4 Mar 2025
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878014
- Sponsor's protocol ID
- SMD-01
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
- ClinicalTrials.gov ID
- NCT06878014
- Acronym / sponsor ID
- SMD-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 monitorIn 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 monitorIn 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 monitorIn addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Incapability to provide informed consent
- Contraindications for spinal anesthesia
- Preoperative chronic pain
- Chronic use of analgesics
- Obesity (BMI>30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | M100, M150, M50 |
| Postoperative pain management with acetaminophenPostoperatively patients received 1,0g of paracetamol every 6 hours, | Drug | M100, M150, M50 |
| PCA IV OxycodoneAll 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. | Device | M100, M150, M50 |
| Postoperative pain management with dexketoprofenPostoperatively patients received 50mg of dexketoprofen intravenously every 8 hours. | Drug | M100, M150, M50 |
| Postoperative pain management with metamizolePostoperatively patients received 1,0g of metamizole intravenously every 6 hours. | Drug | M100, M150, M50 |
| Preemptive AnalgesicsAfter securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole. | Drug | M100, M150, M50 |
| Patient monitorPostoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours. | Device | M100, M150, M50 |
Primary outcome
Analgesic efficacy
Time frame: 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
Time frame: 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.
4 secondary outcomes
Patient satisfaction
Time frame: 48 hours postoperatively
Length of stay
Time frame: Up to one week.
Time to rescue analgesia
Time frame: 48 hours postoperatively
Cumulative dose of oxycodone
Time frame: 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen and PCA IV Oxycodone in people with Analgesics, Opioid and Anesthesia, Spinal, run by Medical University of Silesia at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Szymon Białka, MD PhD (+48323407593, szymon.bialka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficacy (time frame: 48 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.