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Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Primary Purpose

Wrist Disease, Hand Injuries and Disorders

Status

Recruiting

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Sodium Chloride 0.9% Inj

0,1mg/kg Dexamethasone

0,2mg/kg Dexamethasone

About this trial

This is an interventional treatment trial for Wrist 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

Poznan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

placebo injection

0,1mg/kg Dexamethasone

0,2 mg/kg Dexamethasone

Arm Description

5ml of 0,9% sodium chloride - before the popliteal nerve block

0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

0,2 mg/kg dexamethasone sodium phosphate - before the 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 hour during hospitalization

NLR

Neutrophil-to-lymphocyte ratio

PLR

Platelet-to-lymphocyte ratio

Mobilisation

Finger movement every 4 hours

Full Information

NCT ID

NCT05887778

First Posted

May 24, 2023

Last Updated

October 11, 2023

Sponsor

Poznan University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05887778

Brief Title

Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Official Title

Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2023 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

August 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 Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist 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 systemic Dexamethasone. Before the anesthesia, the patients receive Dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg. 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

Wrist Disease, Hand Injuries and Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo injection

Arm Type

Active Comparator

Arm Description

5ml of 0,9% sodium chloride - before the popliteal nerve block

Arm Title

0,1mg/kg Dexamethasone

Arm Type

Active Comparator

Arm Description

0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Arm Title

0,2 mg/kg Dexamethasone

Arm Type

Active Comparator

Arm Description

0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Intervention Type

Drug

Intervention Name(s)

Sodium Chloride 0.9% Inj

Other Intervention Name(s)

placebo

Intervention Description

administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block

Intervention Type

Drug

Intervention Name(s)

0,1mg/kg Dexamethasone

Other Intervention Name(s)

small dose

Intervention Description

administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block

Intervention Type

Drug

Intervention Name(s)

0,2mg/kg Dexamethasone

Other Intervention Name(s)

large dose

Intervention Description

administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus 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 hour 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

Finger 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

Phone

608762068

m.domagalska@icloud.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leszek Romanowski, Prof.dr hab

Organizational Affiliation

Poznań University of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Poznan University of Medical Sciences

City

Poznań

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MAłgorzata Domagalska, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

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