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NCT Number: NCT06878014

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary, Sosnowiec, Silesian Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Anesthesia (bupivacaine)

Procedure

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 acetaminophen

Drug

Postoperatively patients received 1,0g of paracetamol every 6 hours,

PCA IV Oxycodone

Device

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 dexketoprofen

Drug

Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.

Postoperative pain management with metamizole

Drug

Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.

Preemptive Analgesics

Drug

After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.

Patient monitor

Device

Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient satisfaction

    Time frame: 48 hours postoperatively

    Patient satisfaction with pain management measured with Likert scale.

    • Very satisfied.
    • Satisfied.
    • Neither satisfied nor dissatisfied.
    • Dissatisfied.
    • Very dissatisfied.
  2. Length of stay

    Time frame: Up to one week.

    Length of stay postoperatively.

  3. Time to rescue analgesia

    Time frame: 48 hours postoperatively

    Amount of time before first bolus of oxycodone delivered by PCA syringe pump.

  4. Cumulative dose of oxycodone

    Time frame: 48 hours postoperatively

    Cumulative dose of oxycodone over 48 hours postoperatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakub Żak, MD

CONTACT

[email protected]

+48607936667

Szymon Białka, MD PhD

CONTACT

[email protected]

+48323407593

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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