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

Medical University of Silesia

Status and phase: Not yet enrolling; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06878014

SMD-01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

M50

Active Comparator group

Description:

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

Treatment:

Device: PCA IV Oxycodone

Drug: Postoperative pain management with dexketoprofen

Procedure: Spinal Anesthesia (bupivacaine)

Drug: Postoperative pain management with metamizole

Drug: Postoperative pain management with acetaminophen

Drug: Preemptive Analgesics

Device: Patient monitor

M100

Active Comparator group

Description:

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

Treatment:

Device: PCA IV Oxycodone

Drug: Postoperative pain management with dexketoprofen

Procedure: Spinal Anesthesia (bupivacaine)

Drug: Postoperative pain management with metamizole

Drug: Postoperative pain management with acetaminophen

Drug: Preemptive Analgesics

Device: Patient monitor

M150

Active Comparator group

Description:

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

Treatment:

Device: PCA IV Oxycodone

Drug: Postoperative pain management with dexketoprofen

Procedure: Spinal Anesthesia (bupivacaine)

Drug: Postoperative pain management with metamizole

Drug: Postoperative pain management with acetaminophen

Drug: Preemptive Analgesics

Device: Patient monitor