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Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06233604
Enrollment
30
Registered
2024-01-31
Start date
2024-04-10
Completion date
2025-05-30
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic

Brief summary

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip arthroplasty

Detailed description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery. After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect. There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Interventions

unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block

DRUGDexamethasone

unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block

DRUGDexmedetomidine

unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing primary hip arthroplasty * aged \>18 years and \<100 years * ASA physical status 1, 2 or 3.

Exclusion criteria

* if they refused to participate, * had a history of opioid abuse, * had an infection of the site of needle puncture, * were less than 18 years of age, * were postponed as having ASA 4 or 5, * had an allergy to any of the drugs used in the study, * renal failure (estimated glomerular filtration rate \<15ml/min/1.73m2), * liver failure, * known or suspected coagulopathy, * pre-existing anatomical or neurological disorders in the lower extremities, * intellectual disability with problems in pain evaluation, * severe psychiatric illness.

Design outcomes

Primary

MeasureTime frameDescription
first need of opiate48 hours after surgeryTime after surgery when the patient needs opiate for the first time

Secondary

MeasureTime frameDescription
Opioid consumption48 hours after surgeryTotal opiate consumption after surgery
Numerical Rating Scale [range 0:10]4 hours after surgeryNRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
NLR48 hours after surgeryNeutrophil-to-lymphocyte ratio
PLR48 hours after surgeryPlatelet-to-lymphocyte ratio

Countries

Poland

Contacts

Primary ContactMalgorzata Domagalska, Ph.D.
m.domagalska@icloud.com+48 61 873 83 03
Backup ContactMalgorzata Domagalska, Ph.D.
m.domagalska@icloud.com608762068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026