A Phase 4 interventional study of perineural Dexamethasone 4mg and intravenous Dexamethsone 4mg in Osteoarthritis, Hip, Hip Pain Chronic and Hip Arthropathy, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.
Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.
Dexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.
This study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.
The primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.
The results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
PENG block + perineural dexamethasone
Drug: perineural Dexamethasone 4mg
PENG block + intravenous dexamethasone
Drug: intravenous Dexamethsone 4mg
PENG block with 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone
PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone
Time to first rescue opioid analgesia
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Total opioid consumption
Total opioid consumption (mg) converted to morphine milligram equivalents (MME)
Time frame: 48 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Time frame: 4 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Time frame: 8 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Time frame: 12 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Time frame: 24 hours after surgery
NRS
Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Time frame: 48 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Time frame: 12 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Time frame: 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 12 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Time frame: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Time frame: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Time frame: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Time frame: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.
Time frame: 48 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Time frame: 12 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Time frame: 24 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Time frame: 48 hours after surgery
glucose
blood glucose level
Time frame: 12 hours after surgery
glucose
blood glucose level
Time frame: 24 hours after surgery
glucose
blood glucose level
Time frame: 48 hours after surgery
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Poznan University of Medical Sciences