Clinical trial NCT06789328: The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty
Official title: The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Hip Pain Chronic
Hip Arthropathy
Hip Arthritis
Keywords: pericapsular nerve group block
PENG block
adjuvant
dexamethasone
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for total hip arthroplasty
* patients aged \>65 and \<100 years
* patients able to provide informed consent
* patients able to reliably report symptoms to the research team

Exclusion Criteria:

* inability to provide first-party consent due to cognitive impairment or a language barrier
* infection at the site of the regional block,
* coagulation disorders,
* immunodeficiency,
* American Society of Anesthesiologists (ASA) physical status of IV or higher,
* history of regular steroid medication.

Primary outcomes:
measure: Time to first rescue opioid analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Total opioid consumption
timeFrame: 48 hours after surgery
measure: NRS
timeFrame: 4 hours after surgery
measure: NRS
timeFrame: 8 hours after surgery
measure: NRS
timeFrame: 12 hours after surgery
measure: NRS
timeFrame: 24 hours after surgery
measure: NRS
timeFrame: 48 hours after surgery
measure: NLR
timeFrame: 12 hours after surgery
measure: NLR
timeFrame: 24 hours after surgery
measure: NLR
timeFrame: 48 hours after surgery
measure: PLR
timeFrame: 12 hours after surgery
measure: PLR
timeFrame: 24 hours after surgery
measure: PLR
timeFrame: 48 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 4 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 8 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 12 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 24 hours after surgery
measure: Quadriceps muscle strength assessed using medical research council scale [range 0:5]
timeFrame: 48 hours after surgery
measure: Nerve damage
timeFrame: 12 hours after surgery
measure: Nerve damage
timeFrame: 24 hours after surgery
measure: Nerve damage
timeFrame: 48 hours after surgery
measure: glucose
timeFrame: 12 hours after surgery
measure: glucose
timeFrame: 24 hours after surgery
measure: glucose
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznań University of Medical Sciences
name: Malgorzata Reysner, M.D. Ph.D.
role: STUDY_CHAIR
References: