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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial

ConditionsOsteoarthritis, HipHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorPoznan University of Medical Sciences

About this trial

his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Scheduled for elective total hip arthroplasty (THA)

Planned use of regional anesthesia including PENG block

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

Disqualifiers

Known hypersensitivity to dexamethasone or any component of the study medication

Chronic corticosteroid therapy or use of systemic steroids within 14 days prior to surgery

Active systemic infection or sepsis

Significant immunosuppression (e.g., chemotherapy, biological therapy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone 4mg

    Drug

    Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg

  • Placebo

    Drug

    Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia.

  • Dexamethasone 8mg

    Drug

    Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg

Treatment groups

198 Participants
are divided into 3 treatment groups
Group A: Placebo (0 mg Intravenous Dexamethasone)Placebo comparator 1 intervention
Group B: Dexamethasone 4 mg IntravenousActive comparator 1 intervention
Group C: Dexamethasone 8 mg IntravenousActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Rescue Analgesia

Time from the end of surgery to the first administration of rescue analgesia (opioid) due to inadequate pain control (Numeric Rating Scale ≥ 4 or patient request).

Time frame
48 hours after surgery

Secondary outcomes

1

Postoperative Pain Intensity

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
6 hours after surgery
2

Postoperative Pain Intensity

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
12 hours after surgery
3

Postoperative Pain Intensity

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
24 hours after surgery
4

Postoperative Pain Intensity

Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

Time frame
48 hours after surgery

Other outcomes

Sponsors and contacts

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Poznan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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