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Clinical Trials/NCT06470100
NCT06470100RecruitingPhase 4

Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Total Knee Arthroplasty

Poznan University of Medical Sciences1 site in 1 country90 target enrollmentStarted: August 13, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
first need of opiate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Control group

Placebo Comparator

0.2% ropivacaine for erector spinae plane block

Intervention: 0.9% Sodium Chloride Injection (Drug)

Dexamethasone

Experimental

0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block

Intervention: Dexamethasone (Drug)

Dexmedetomidine

Experimental

0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block

Intervention: Dexmedetomidine (Drug)

Outcomes

Primary Outcomes

first need of opiate

Time Frame: 48 hours after surgery

Time after surgery when the patient needs opiate for the first time

Secondary Outcomes

  • Opioid consumption(48 hours after surgery)
  • Numerical Rating Scale [range 0:10](48 hours after surgery)
  • Nerve damage [range 0-4](48 hours after surgery)

Investigators

Sponsor
Poznan University of Medical Sciences
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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