Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06086418
Collaborator
(none)
90
3
13

Study Details

Study Description

Brief Summary

Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.9 % Sodium Chloride
  • Drug: 0.1mg/kg Dexamethasone
  • Drug: 0.05mg/kg Dexamethasone
Phase 4

Detailed Description

This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.

After hand and wrist 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, 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 use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.

The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously 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:
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle 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 popliteal nerve block

Drug: 0.9 % Sodium Chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
Other Names:
  • placebo
  • Active Comparator: 0.1mg/kg Dexamethasone

    0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

    Drug: 0.1mg/kg Dexamethasone
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
    Other Names:
  • large dose
  • Active Comparator: 0,05mg/kg dexamethasone

    0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

    Drug: 0.05mg/kg Dexamethasone
    administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block
    Other Names:
  • small dose
  • 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. Pain score [4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery]

      children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)

    3. Blood glucose [24 and 48 hours after surgery]

      Blood glucose every 24 hours during hospitalization

    4. NLR [24 and 48 hours after surgery]

      Neutrophil-to-lymphocyte ratio

    5. PLR [24 and 48 hours after surgery]

      Platelet-to-lymphocyte ratio

    6. Mobilisation [4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery]

      Toe movement every 4 hours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • children scheduled for hand/wrist surgery

    • body weight > 5kg

    Exclusion Criteria:
    • 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:
    NCT06086418
    Other Study ID Numbers:
    • 13/2023
    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:

    Study Results

    No Results Posted as of Oct 17, 2023