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

P

Poznan University of Medical Sciences (PUMS)

Status and phase

Enrolling
Phase 4

Conditions

Hip Arthropathy
Hip Osteoarthritis
Hip Pain Chronic

Treatments

Drug: Dexmedetomidine
Drug: Dexamethasone
Drug: 0.9%sodium chloride

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
0.2% ropivacaine for erector spinae plane block
Treatment:
Drug: 0.9%sodium chloride
Dexamethasone
Experimental group
Description:
0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Treatment:
Drug: Dexamethasone
Dexmedetomidine
Experimental group
Description:
0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Malgorzata Domagalska, Ph.D.; Malgorzata Domagalska, Ph.D.

Data sourced from clinicaltrials.gov

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