Dexamethasone given IV versus perineural to prolong pain relief after pediatric arm nerve block.
The Effect of Dexamethasone Administration Route in Infraclavicular Brachial Plexus Block for Pediatric Arm and/or Hand Surgery
We will test whether giving dexamethasone through a vein (IV) or around the nerve (perineural) gives better pain control and less inflammation for children having arm surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Months to 6 Years |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 2 sites (Poznan and 1 other locations) |
| Trial ID | NCT07061678 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded Phase 4 trial enrolls pediatric patients undergoing elective arm, wrist, or hand surgery and compares IV dexamethasone to perineural dexamethasone given with an infraclavicular brachial plexus block. Participants receive standardized spinal anesthesia under mild sedation and an infraclavicular block using 0.2 ml/kg of 0.2% ropivacaine, with the dexamethasone route blinded. The primary outcome is time to first request for rescue analgesia, and secondary outcomes include postoperative pain scores at predefined intervals, inflammatory markers (NLR and PLR), total opioid consumption, and blood glucose. Randomization and blinding are used to minimize bias and directly compare analgesic duration and inflammatory response between the two administration routes.
Who should consider this trial
Good fit: Children weighing more than 5 kg who are scheduled for elective arm, wrist, or hand surgery and who do not have infection at the block site, coagulation disorders, immunodeficiency, or regular steroid use.
Not a fit: Children with active infection at the block site, bleeding or coagulation disorders, immunodeficiency, ASA physical status IV or higher, or those on regular steroid medication are not expected to benefit or would be ineligible.
Why it matters
Potential benefit: If successful, this could lengthen pain relief after nerve block, reduce opioid use, and speed recovery for children after arm surgery.
How similar studies have performed: Adult studies and some small pediatric reports have shown that perineural dexamethasone can prolong peripheral nerve block analgesia, but robust pediatric evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children scheduled for arm/wrist/hand surgery * body weight \> 5kg Exclusion Criteria: * infection at the site of the regional block, * coagulation disorders, * immunodeficiency, * American Society of Anesthesiologists (ASA) physical status of IV or higher, * history of regular steroid medication.
Where this trial is running
Poznan and 1 other locations
- Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
- Poznan University of Medical Sciences — Poznan, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Malgorzata Reysner, M.D. Ph.D. — Poznan University of Medicl Sciences
- Study coordinator: Malgorzata Reysner, M.D. Ph.D.
- Email: mreysner@ump.edu.pl
- Phone: +48 61 873 83 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.