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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755880
• Other study ID #: LDDLA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: Ahmed Khashaba, MD
• Phone: 0201023233949
• Email: DOCTORAHMEDKHASHABA[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	Visual analogue scale (VAS) for assessment of children's pain perception	30 minutes after recovery