Different spinal morphine doses for pain relief after hip replacement
Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
This trial tests whether different doses of morphine given with spinal anesthesia reduce pain and balance safety after total hip replacement in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 3 sites (Sosnowiec, Silesian Voivodeship and 2 other locations) |
| Trial ID | NCT06878014 on ClinicalTrials.gov |
What this trial studies
Adults having elective total hip replacement receive spinal bupivacaine combined with varying doses of intrathecal morphine and standardized postoperative multimodal analgesia, including acetaminophen, an NSAID or metamizole, and PCA IV oxycodone as needed. The study tracks pain scores, opioid consumption, and adverse events—with particular attention to respiratory depression—primarily during the first 24 hours after surgery. Eligible participants are ASA I–III with BMI 19–30, able to use a PCA pump, and without chronic preoperative opioid use or contraindications to spinal anesthesia. The goal is to find a morphine dose that prolongs pain relief while minimizing serious side effects.
Who should consider this trial
Good fit: Adults scheduled for elective total hip replacement who are ASA physical status I–III, have BMI 19–30, can operate a PCA pump, and can give informed consent are ideal candidates.
Not a fit: Patients with BMI over 30, chronic preoperative pain or regular opioid use, contraindications to spinal anesthesia, or inability to use a PCA pump may not receive benefit from the study findings.
Why it matters
Potential benefit: If successful, the trial could identify a morphine dose that provides longer post-operative pain relief with fewer serious side effects like respiratory depression.
How similar studies have performed: Prior research shows intrathecal morphine prolongs postoperative analgesia but carries dose-dependent risk of respiratory depression, so dose-finding work is common and needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sosnowiec, Silesian Voivodeship and 2 other locations
- 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)
Study contacts
- Study coordinator: Szymon Białka, MD PhD
- Email: szymon.bialka@gmail.com
- Phone: +48323407593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.