Low Dose Dexamethasone to Local Anesthetic in Caudal Analgesia on Healing Process After Orthopaedic Surgery

NCT ID: NCT05755880

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Long-term corticosteroids prescribing was associated with many adverse effects, as increased skin pigmentation, lowering immunity (catching opportunistic infections like herpes zoster, candida and cutaneous abscesses or even flaring localized infections), resistant hyperglycemia, renal impairment, hypertension, impaired healing, thinning skin that bruises easily, adrenal gland suppression, facial erythema, stria, acne, mild hirsutism, blurring vision, muscle weakness, glaucoma, cataract, thinning of hair, osteoporosis, and psychiatric disturbances (including mood fluctuations, depression or manic disorders).

Localized infection at site of injection is a known logical absolute contraindication for any injection including corticosteroids due to fearing of flaring of infection. Also, there is no single published article discussing an infection due to corticosteroids injection as an adjuvant to local anesthetics as it is always explained by inadequate aseptic technique performance.

In this study we will search if there is a role for corticosteroids in delaying healing process after orthopedic surgery. And compare the incidence of postoperative infection after surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

General anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Dexamethason

Group Type ACTIVE_COMPARATOR

Intrathecal dexamethason

Intervention Type PROCEDURE

After general anesthesia intrathecal dexamthasone will be added

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrathecal dexamethason

After general anesthesia intrathecal dexamthasone will be added

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1- Open fractures 2. Infected surgery 3. Hypersensitivity to dexamethasone 4. Bad nutritional conditions as Marasmus, Cerebral palsy and Kwashiorkor
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bahaaeldin Mohamed Abdelhafez

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed Khashaba, MD

Role: CONTACT

0201023233949

Ayman Abou-Galalah, MD

Role: CONTACT

0201025675901

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24413428 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LDDLA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IV Dexamethasone in Preventing Post Spinal Hypotension
NCT07052864 ACTIVE_NOT_RECRUITING PHASE4
Intravenous Regional Analgesia of Dexmedetomidine
NCT07131579 ENROLLING_BY_INVITATION NA