NCT05755880

Brief Summary

Addition of dexamethasone to local anesthetics infiltration has been proven to augment postoperative analgesia, prolongs anesthesia time and sometimes reduces the needed dose of local anesthetics and consequently, decreases their side effects and enhances early ambulation and hospital discharge (mainly due to decreased need for opioid use

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 23, 2023

Last Update Submit

February 23, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    Visual analogue scale (VAS) for assessment of children's pain perception

    30 minutes after recovery

Study Arms (2)

General anesthesia

NO INTERVENTION

Dexamethason

ACTIVE COMPARATOR
Procedure: Intrathecal dexamethason

Interventions

Intrathecal dexamethasonPROCEDURE

After general anesthesia intrathecal dexamthasone will be added

Dexamethason

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Age: 1month up to 18 years old 2. Orthopaedic surgeries with average time up to one hour 3. Traumatic and orthopaedic indications for surgery

You may not qualify if:

  • Open fractures 2. Infected surgery 3. Hypersensitivity to dexamethasone 4. Bad nutritional conditions as Marasmus, Cerebral palsy and Kwashiorkor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.

    PMID: 24413428BACKGROUND

Central Study Contacts

Ahmed Khashaba, MD

CONTACT

0201023233949DOCTORAHMEDKHASHABA@gmail.com

Ayman Abou-Galalah, MD

CONTACT

0201025675901Aymanglala@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

December 1, 2024

Last Updated

March 6, 2023

Record last verified: 2023-02