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

Phase 4

Not yet recruiting

• Conditions: Analgesics, Opioid; Anesthesia, Spinal; Total Hip Replacement; Adverse Anesthesia Outcome
• Interventions: 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

• Registration Number: NCT06878014
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-04
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M50	Spinal Anesthesia (bupivacaine)	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	Postoperative pain management with acetaminophen	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	PCA IV Oxycodone	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	Postoperative pain management with dexketoprofen	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	Postoperative pain management with metamizole	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	Preemptive Analgesics	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M50	Patient monitor	In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
M100	Spinal Anesthesia (bupivacaine)	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	Postoperative pain management with acetaminophen	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	PCA IV Oxycodone	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	Postoperative pain management with dexketoprofen	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	Postoperative pain management with metamizole	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	Preemptive Analgesics	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M100	Patient monitor	In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
M150	Spinal Anesthesia (bupivacaine)	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	Postoperative pain management with acetaminophen	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	PCA IV Oxycodone	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	Postoperative pain management with dexketoprofen	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	Postoperative pain management with metamizole	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	Preemptive Analgesics	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
M150	Patient monitor	In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy	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.
Safety profile	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	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.
Length of stay	Up to one week.	Length of stay postoperatively.
Time to rescue analgesia	48 hours postoperatively	Amount of time before first bolus of oxycodone delivered by PCA syringe pump.
Cumulative dose of oxycodone	48 hours postoperatively	Cumulative dose of oxycodone over 48 hours postoperatively.

Trial Locations

Locations (2)

Wojewódzki Szpital Specjalistyczny nr 5 im. św. Barbary; 🇵🇱 Sosnowiec, Silesia, Poland

Zespół Opieki Zdrowotnej w Końskich; 🇵🇱 Końskie, Świętokrzyskie, Poland