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Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06086431
Collaborator
(none)
90
Enrollment
3
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

0.2% ropivacaine for erector spinae plane block

Drug: 0.9% sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
Other Names:
  • placebo

    		•
    Active Comparator: Dexamethasone

    0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block

    Drug: Dexamethasone
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
    Active Comparator: Dexmedetomidine

    0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block

    Drug: Dexmedetomidine
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block

    Outcome Measures

    Primary Outcome Measures

    1. first need of opiate [48 hours]

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

    Secondary Outcome Measures

    1. Opioid consumption [48 hours]

      Total opiate consumption after surgery

    2. Numerical Rating Scale [range 0:10] [4 hours after surgery]

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

    3. Numerical Rating Scale [range 0:10] [8 hours after surgery]

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

    4. Numerical Rating Scale [range 0:10] [12 hours after surgery]

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

    5. Numerical Rating Scale [range 0:10] [16 hours after surgery]

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

    6. Numerical Rating Scale [range 0:10] [20 hours after surgery]

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

    7. Numerical Rating Scale [range 0:10] [24 hours after surgery]

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

    8. NLR [24 and 48 hours after surgery]

      Neutrophil-to-lymphocyte ratio

    9. PLR [24 and 48 hours after surgery]]

      Platelet-to-lymphocyte ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • children scheduled for idiopathic scoliosis surgery

    • age >10 and <18 years

    Exclusion Criteria:

    • age < 10 years

    • age < 18 years

    • infection at the site of the regional blockade

    • coagulation disorders

    • immunodeficiency

    • ASA= or >4

    • steroid medication in regular use

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Poznan University of Medical Sciences

    Investigators

    • Study Director: Tomasz Kotwicki, Prof.dr hab., Poznan University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poznan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT06086431
    Other Study ID Numbers:
    • 14/2023
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Scoliosis
    Dexamethasone
    Dexmedetomidine

    Study Results

    No Results Posted as of Oct 17, 2023