Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-100
SponsorPoznan University of Medical Sciences

About this trial

The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.

The main questions this study aims to answer are:

Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.

Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.

The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 60 to 100 years

Scheduled for elective total hip arthroplasty

American Society of Anesthesiologists (ASA) physical status I-III

Ability to understand the study procedures and provide written informed consent

Disqualifiers

Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone

Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks

Infection at the site of spinal or peripheral nerve block injection

Pre-existing neurological disorders affecting sensory or motor function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine

    Drug

    Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.

  • Pericapsular Nerve Group Block

    Procedure/Surgery

    Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.

  • Dexamethasone

    Drug

    Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Spinal Anesthesia With Intrathecal MorphineActive comparator 1 intervention
Group B: Spinal Anesthesia Plus PENG BlockExperimental treatment 1 intervention
Group C: Spinal Anesthesia Plus PENG Block With DexamethasoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Postoperative Opioid Consumption

Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.

Time frame
Up to 48 hours after surgery

Secondary outcomes

1

Pain scores at rest

Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization

Time frame
6 hours after surgery
2

Pain scores durring movement

Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization

Time frame
6 hours after surgery
3

Pain scores at rest

Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization

Time frame
12 hours after surgery
4

Pain scores durring movement

Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")- at rest and during mobilization

Time frame
12 hours after surgery

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: