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

February 11, 2026 updated by: Medical University of Silesia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
    • Silesian Voivodeship
      • Sosnowiec, Silesian Voivodeship, Poland, 41-214
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary
        • Contact:
        • Sub-Investigator:
          • Jakub Żak, MD
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-204
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie
    • Świętokrzyskie Voivodeship
      • Gmina Końskie, Świętokrzyskie Voivodeship, Poland, 26-200
        • Recruiting
        • Zespół Opieki Zdrowotnej w Końskich
        • Principal Investigator:
          • Wojciech Gola, MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
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 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).
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.
Active Comparator: M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
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 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).
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.
Active Comparator: M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
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 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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analgesic efficacy
Time Frame: 48 hours postoperatively
Analgesic efficacy defined as mean value of NRS (Numerical Rating Scale) at 4, 8, 12 ,24 and 48 hours postoperatively at rest and during rehabilitation/movement.
48 hours postoperatively
Safety profile
Time Frame: 48 hours postoperatively
Frequency of adverse events including excessive sedation (defined as Richmond Agitation Sedation Score RASS≤-1), constipation, postoperative nausea and vomiting, pruritus and respiratory depression defined as sudden drop in respiration rate by ≥90% for ≥10 seconds or cyanosis.
48 hours postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 48 hours postoperatively

Patient satisfaction with pain management measured with Likert scale.

  1. Very satisfied.
  2. Satisfied.
  3. Neither satisfied nor dissatisfied.
  4. Dissatisfied.
  5. Very dissatisfied.
48 hours postoperatively
Length of stay
Time Frame: Up to one week.
Length of stay postoperatively.
Up to one week.
Time to rescue analgesia
Time Frame: 48 hours postoperatively
Amount of time before first bolus of oxycodone delivered by PCA syringe pump.
48 hours postoperatively
Cumulative dose of oxycodone
Time Frame: 48 hours postoperatively
Cumulative dose of oxycodone over 48 hours postoperatively.
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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