Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID06878014

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

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)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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

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