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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05755880
Collaborator
(none)
60
2
21.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intrathecal dexamethason
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Addition of Single Low Dose Dexamethasone to Local Anesthetic in Caudal Analgesia on Healing Process After Pediatric and Adolescent Orthopaedic Surgery
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: General anesthesia

Active Comparator: Dexamethason

Procedure: Intrathecal dexamethason
After general anesthesia intrathecal dexamthasone will be added

Outcome Measures

Primary Outcome Measures

  1. Visual analogue scale [30 minutes after recovery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahaaeldin Mohamed Abdelhafez, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05755880
Other Study ID Numbers:
  • LDDLA
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 6, 2023