Actively Recruiting
Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement
Led by Medical University of Silesia · Updated on 2026-02-12
120
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different doses of morphine administered during spinal anesthesia to manage pain after total hip replacement surgery. The study focuses on balancing the benefits of morphine's long-lasting pain relief with the risks, especially respiratory depression, which requires precise dosing. This Phase 4 trial is sponsored by the Medical University of Silesia and investigates doses of 50 mcg, 100 mcg, and 150 mcg of morphine given intrathecally alongside bupivacaine. Patients receive spinal anesthesia with 15 mg of 0.5% bupivacaine through a carefully performed spinal puncture. Along with bupivacaine, they are randomly assigned to one of three groups receiving different doses of morphine intrathecally: 50 mcg, 100 mcg, or 150 mcg. Postoperative pain management includes scheduled doses of paracetamol, dexketoprofen, and metamizole, as well as patient-controlled analgesia (PCA) with oxycodone administered via a syringe pump. Continuous vital signs monitoring occurs for 48 hours after surgery. Participants will be observed for 48 hours after surgery to assess pain relief and safety outcomes. Researchers will measure analgesic efficacy, patient satisfaction, time to additional analgesia, total oxycodone use, and length of hospital stay up to one week. Continuous monitoring and questionnaires will help evaluate the safety profile and patient recovery. The trial enrollment includes adults aged 18 to 75 years undergoing total hip replacement surgery.
CONDITIONS
Brief Title
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total hip replacement surgery with spinal anesthesia including bupivacaine and a dose of intrathecal morphine.
1 surgical procedure visit (in-person)
Duration - 48 hours postoperatively
Participants receive postoperative pain management with acetaminophen, dexketoprofen, metamizole, and PCA IV oxycodone, while vital signs are continuously monitored.
Continuous monitoring and medication administration during hospital stay
Duration - Up to one week
Participants are observed for analgesic efficacy, safety, patient satisfaction, and recovery progress including length of hospital stay.
Follow-up visits during hospital stay
Trial Site Locations
Total: 3 locations
1
Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary
Sosnowiec, Silesian Voivodeship, Poland, 41-214
Actively Recruiting
2
Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie
Szczecin, West Pomeranian Voivodeship, Poland, 70-204
Not Yet Recruiting
3
Zespół Opieki Zdrowotnej w Końskich
Gmina Końskie, Świętokrzyskie Voivodeship, Poland, 26-200
Actively Recruiting
Research Team
S
Szymon Białka, MD PhD
J
Jakub Żak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3