What is dexamethasone and dexmedetomidine studying for pain after spine surgery?

Researchers are studying whether dexamethasone or dexmedetomidine works better and is safer when added to a nerve block to reduce pain after lumbar spine surgery. This trial aims to help doctors choose the best pain management approach while lowering the need for opioids. The study is led by Poznan University of Medical Sciences.

Who may be eligible for this spine surgery clinical trial?

Adults aged 18 years and older scheduled for elective lumbar spine surgery may be eligible. Participants must weigh at least 50 kg and have an ASA physical status of I to III. Those with allergies to study drugs or certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this spine surgery clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07180940

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

Led by Poznan University of Medical Sciences · Updated on 2025-09-18

150

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating which medication, dexamethasone or dexmedetomidine, works better and is safer when added to a local anesthetic called ropivacaine in a nerve block named the erector spinae plane block ESPB. This nerve block helps reduce pain after lumbar spine surgery. This phase 4, randomized, double-blind trial aims to improve pain management while reducing opioid use and their side effects after spine surgery. All participants will undergo general anesthesia for lumbar spine surgery and receive a bilateral ESPB using ultrasound guidance. The nerve block will include ropivacaine combined with either dexamethasone, dexmedetomidine, or a placebo saline. Participants are randomly assigned to one of these three groups, and neither patients nor pain assessors will know which medication was used. During the study, researchers will monitor opioid use during the first 24 and 48 hours after surgery as the main outcome. They will also assess pain intensity at multiple time points, time to first pain relief, any nerve injuries, side effects such as nausea or low blood pressure, and laboratory markers like blood glucose and inflammation ratios. Participants are expected to stay in the hospital for at least 48 hours for monitoring and assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Scheduled for elective lumbar spine surgery via posterior approach
American Society of Anesthesiologists (ASA) physical status I to III
Body weight at least 50 kilograms
Ability to provide written informed consent
Expected postoperative hospital stay of at least 48 hours

You will not qualify if you...

Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine
Infection at or near the site of nerve block
Coagulation disorders or ongoing anticoagulant therapy not stopped as per guidelines
Chronic opioid use or opioid dependence
Neurological or psychiatric disorders affecting pain assessment
Poorly controlled diabetes (e.g., HbA1c over 8%)
Severe liver or kidney dysfunction
Body mass index (BMI) over 40 kg/m2
Pregnancy or breastfeeding
Refusal or inability to cooperate with study procedures

Research Team

Malgorzata Reysner, M.D. Ph.D.

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