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Recruiting NCT06878014

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

Phase IV Interventional Analgesics, Opioid Anesthesia, Spinal Total Hip Replacement Adverse Anesthesia Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Anesthesia (bupivacaine), Postoperative pain management with acetaminophen, PCA IV Oxycodone, Postoperative pain management with dexketoprofen.
Who it may be relevant to
Registry conditions: Analgesics, Opioid, Anesthesia, Spinal, Total Hip Replacement, Adverse Anesthesia Outcome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure 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
  • Drug Postoperative pain management with acetaminophen
    Postoperatively patients received 1,0g of paracetamol every 6 hours,
  • Device PCA IV Oxycodone
    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.
  • Drug Postoperative pain management with dexketoprofen
    Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
  • Drug Postoperative pain management with metamizole
    Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
  • Drug Preemptive Analgesics
    After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
  • Device Patient monitor
    Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.

Primary outcome measures

  • Analgesic efficacy [Time frame: 48 hours postoperatively]
  • Safety profile [Time frame: 48 hours postoperatively]
Secondary outcome measures (4)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Poland · 3 centers
  • Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary — Sosnowiec
  • Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie — Szczecin
  • Zespół Opieki Zdrowotnej w Końskich — Gmina Końskie

Identifiers

NCT: NCT06878014 · SMD-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗