Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
NCT ID: NCT06878014
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2025-03-04
2026-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
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 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
Postoperatively patients received 1,0g of paracetamol every 6 hours,
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.
Postoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
Postoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
Preemptive Analgesics
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
Patient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
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 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
Postoperatively patients received 1,0g of paracetamol every 6 hours,
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.
Postoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
Postoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
Preemptive Analgesics
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
Patient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
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 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
Postoperatively patients received 1,0g of paracetamol every 6 hours,
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.
Postoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
Postoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
Preemptive Analgesics
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
Patient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
Interventions
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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 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
Postoperatively patients received 1,0g of paracetamol every 6 hours,
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.
Postoperative pain management with dexketoprofen
Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.
Postoperative pain management with metamizole
Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.
Preemptive Analgesics
After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.
Patient monitor
Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Locations
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Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary
Sosnowiec, Silesian Voivodeship, Poland
Zespół Opieki Zdrowotnej w Końskich
Gmina Końskie, Świętokrzyskie Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SMD-01
Identifier Type: -
Identifier Source: org_study_id
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