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

NCT06878014 | Recruiting Phase 4

• 1 other identifier: SMD-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Analgesics, Opioid; Anesthesia, Spinal; Total Hip Replacement; Adverse Anesthesia Outcome

Outcome Measures

Primary Outcomes (2)

• Analgesic efficacy

  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

  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 Outcomes (4)

• Patient satisfaction

  48 hours postoperatively

• Length of stay

  Up to one week.

• Time to rescue analgesia

  48 hours postoperatively

• Cumulative dose of oxycodone

  48 hours postoperatively

Study Arms (3)

M50

ACTIVE COMPARATOR

In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.

Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor

M100

ACTIVE COMPARATOR

In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.

Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor

M150

ACTIVE COMPARATOR

In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.

Procedure: Spinal Anesthesia (bupivacaine); Drug: Postoperative pain management with acetaminophen; Device: PCA IV Oxycodone; Drug: Postoperative pain management with dexketoprofen; Drug: Postoperative pain management with metamizole; Drug: Preemptive Analgesics; Device: Patient monitor

Interventions

Spinal Anesthesia (bupivacaine) PROCEDURE

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).

M100; M150; M50

Postoperative pain management with acetaminophen DRUG

Postoperatively patients received 1,0g of paracetamol every 6 hours,

M100; M150; M50

PCA IV Oxycodone DEVICE

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.

M100; M150; M50

Postoperative pain management with dexketoprofen DRUG

Postoperatively patients received 50mg of dexketoprofen intravenously every 8 hours.

M100; M150; M50

Postoperative pain management with metamizole DRUG

Postoperatively patients received 1,0g of metamizole intravenously every 6 hours.

M100; M150; M50

Preemptive Analgesics DRUG

After securing intravenous line each patient received preemptive analgesia with 1,0g paracetamol and 1,0g metamizole.

M100; M150; M50

Patient monitor DEVICE

Postoperatively each patient's vital signs were monitored continuously using patient monitor for 48 hours.

M100; M150; M50

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (3)

Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary

Sosnowiec, Silesian Voivodeship, 41-214, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego PUM w Szczecinie

Szczecin, West Pomeranian Voivodeship, 70-204, Poland

NOT YET RECRUITING

Zespół Opieki Zdrowotnej w Końskich

Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine; Acetaminophen; dexketoprofen trometamol; Dipyrone; Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Szymon Białka, MD PhD

CONTACT

+48323407593; szymon.bialka@gmail.com

Jakub Żak, MD

CONTACT

+48607936667; jakubzak.sum@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

PL (3)