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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of Silesia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent to participate in trial

Qualification for total hip replacement surgery

ASA physical status I-III

BMI 19-30

Disqualifiers

Incapability to provide informed consent

Contraindications for spinal anesthesia

Preoperative chronic pain

Chronic use of analgesics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Anesthesia (bupivacaine)

    Procedure/Surgery

    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

    Drug

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

  • 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.

  • Postoperative pain management with dexketoprofen

    Drug

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

  • Postoperative pain management with metamizole

    Drug

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

  • Preemptive Analgesics

    Drug

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

  • Patient monitor

    Device

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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: M50Active comparator 7 interventions
Group B: M100Active comparator 7 interventions
Group C: M150Active comparator 7 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
48 hours postoperatively
2

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.

Time frame
48 hours postoperatively

Secondary outcomes

1

Patient satisfaction

Patient satisfaction with pain management measured with Likert scale. 1. Very satisfied. 2. Satisfied. 3. Neither satisfied nor dissatisfied. 4. Dissatisfied. 5. Very dissatisfied.

Time frame
48 hours postoperatively
2

Length of stay

Length of stay postoperatively.

Time frame
Up to one week.
3

Time to rescue analgesia

Amount of time before first bolus of oxycodone delivered by PCA syringe pump.

Time frame
48 hours postoperatively
4

Cumulative dose of oxycodone

Cumulative dose of oxycodone over 48 hours postoperatively.

Time frame
48 hours postoperatively

Other outcomes

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