Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoznan University of Medical Sciences

About this trial

This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to N/A (no limit)

Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach

American Society of Anesthesiologists (ASA) physical status I-III

Body weight ≥ 50 kg

Disqualifiers

Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine

Infection at or near the site of block placement

Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines)

Chronic opioid use or opioid dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.9%NaCl

    Drug

    2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl

  • Dexamethasone 4mg

    Drug

    2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone

  • Dexmedetomidine

    Drug

    2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Dexamethasone groupExperimental treatment 1 intervention
Group C: Dexmedetomidine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total opioid Consuption

Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME)

Time frame
48 hours after surgery

Secondary outcomes

1

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame
4 hours after surgery
2

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame
8 hours after surgery
3

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame
12 hours after surgery
4

NRS

Numerical Rating Scale (0 - no pain; 10 - the worst pain ever)

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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