Clinical trial NCT06470100: Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty
Official title: Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Disease
Knee Pain Chronic
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee 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.

Local anaesthesia's much lower toxicity threshold makes it essential for its safety. 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 comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine 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.

Eligibility criteria: 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.

Primary outcomes:
measure: first need of opiate
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 4 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 8 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 12 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 16 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 20 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 24 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 36 hours after surgery
measure: Numerical Rating Scale [range 0:10]
timeFrame: 48 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 12 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 24 hours after surgery
measure: Nerve damage [range 0-4]
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Science
name: Malgorzata Domagalska, M.D. PhD.
role: STUDY_CHAIR
References: