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NCT Number: NCT07180940

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

About this study

All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.

The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.

This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability to provide written informed consent
  • Expected postoperative hospitalization of at least 48 hours

Exclusion criteria

  • 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
  • Neurological or psychiatric disorders interfering with pain assessment
  • Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c > 8%)
  • Severe hepatic or renal dysfunction
  • Body mass index (BMI) > 40 kg/m²
  • Pregnancy or breastfeeding
  • Refusal or inability to cooperate with the study protocol

Treatment and study plan

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

Primary outcomes

  1. Total opioid Consuption

    Time frame: 48 hours after surgery

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

Secondary outcomes

  1. NRS

    Time frame: 4 hours after surgery

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

  2. NRS

    Time frame: 8 hours after surgery

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

  3. NRS

    Time frame: 12 hours after surgery

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

  4. NRS

    Time frame: 24 hours after surgery

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

  5. NRS

    Time frame: 48 hours after surgery

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

  6. Nerve injury

    Time frame: 12 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  7. Nerve injury

    Time frame: 24 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  8. Nerve injury

    Time frame: 48 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  9. adverce effects

    Time frame: 48 hours after surgery

    nausea, vomitting, bradycardia, hypotension

  10. Time to first rescue analgesia

    Time frame: 48 hours after surgery

    Time after surgery when the patient needs rescue analgesia for the first time

  11. blood glucose

    Time frame: 12 hours after surgery

    Blood glucose concentration measured postoperatively

  12. blood glucose

    Time frame: 24 hours after surgery

    Blood glucose concentration measured postoperatively

  13. blood glucose

    Time frame: 48 hours after surgery

    Blood glucose concentration measured postoperatively

  14. NLR - Neutrophil-to-Lymphocyte Ratio

    Time frame: 12 hours after surgery

    NLR will be calculated from complete blood count results

  15. NLR - Neutrophil-to-Lymphocyte Ratio

    Time frame: 24 hours after surgery

    NLR will be calculated from complete blood count results

  16. NLR - Neutrophil-to-Lymphocyte Ratio

    Time frame: 48 hours after surgery

    NLR will be calculated from complete blood count results

  17. PLR - Platelet-to-Lymphocyte Ratio

    Time frame: 12 hours after surgery

    PLR will be calculated from complete blood count results

  18. PLR - Platelet-to-Lymphocyte Ratio

    Time frame: 24 hours after surgery

    PLR will be calculated from complete blood count results

  19. PLR - Platelet-to-Lymphocyte Ratio

    Time frame: 48 hours after surgery

    PLR will be calculated from complete blood count results

Study contacts

Contact information is provided by the study sponsor or research team.

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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