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

Primary Purpose

Ankle Disease, Ankle Injuries, Foot Injury

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

0.9 % Sodium Chloride

0.1mg/kg Dexamethasone

0.05mg/kg Dexamethasone

About this trial

This is an interventional treatment trial for Ankle Disease

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

0.1mg/kg Dexamethasone

0,05mg/kg dexamethasone

Arm Description

0.2% ropivacaine for popliteal nerve block

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

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

Outcomes

Primary Outcome Measures

first need of opiate

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

Secondary Outcome Measures

Opioid Consumption

Total opiate consumption after surgery

Pain score

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

Blood glucose

Blood glucose every 24 hours during hospitalization

NLR

Neutrophil-to-lymphocyte ratio

PLR

Platelet-to-lymphocyte ratio

Mobilisation

Toe movement every 4 hours

Full Information

NCT ID

NCT06086418

First Posted

October 11, 2023

Last Updated

October 11, 2023

Sponsor

Poznan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT06086418

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Disease, Ankle Injuries, Foot Injury, Foot Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

0.2% ropivacaine for popliteal nerve block

Arm Title

0.1mg/kg Dexamethasone

Arm Type

Active Comparator

Arm Description

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

Arm Title

0,05mg/kg dexamethasone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.9 % Sodium Chloride

Other Intervention Name(s)

placebo

Intervention Description

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block

Intervention Type

Drug

Intervention Name(s)

0.1mg/kg Dexamethasone

Other Intervention Name(s)

large dose

Intervention Description

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block

Intervention Type

Drug

Intervention Name(s)

0.05mg/kg Dexamethasone

Other Intervention Name(s)

small dose

Intervention Description

administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block

Primary Outcome Measure Information:

Title

first need of opiate

Description

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Opioid Consumption

Description

Total opiate consumption after surgery

Time Frame

48 hours

Title

Pain score

Description

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

Time Frame

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

Title

Blood glucose

Description

Blood glucose every 24 hours during hospitalization

Time Frame

24 and 48 hours after surgery

Title

NLR

Description

Neutrophil-to-lymphocyte ratio

Time Frame

24 and 48 hours after surgery

Title

PLR

Description

Platelet-to-lymphocyte ratio

Time Frame

24 and 48 hours after surgery

Title

Mobilisation

Description

Toe movement every 4 hours

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Małgorzata Domagalska, Ph.D.

Phone

+48 608762068

m.domagalska@icloud.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tomasz Kotwicki, Prof.dr hab.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomasz Kotwicki, Prof.dr hab.

Organizational Affiliation

Poznan University of Medical Sciences

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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