A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Blocks

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20150624001
• Date of registration: 24/06/2015
• Prospective Registration: Yes
• Primary sponsor: No sponsor
• Public title: A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Blocks
• Scientific title: A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Blocks
• Date of first enrolment: 01/07/2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20150624001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2/Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Vanlapa Arnuntasupakul
• Affiliation: Mahidol University

• Name: Vanlapa Arnuntasupakul
• Affiliation: Mahidol University

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing upper extremity surgery (elbow and below) with
- American Society of Anesthesiologists classification 1-3
- body mass index between 18 and 35
Exclusion criteria: - adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to local anesthetics (LAs)
- pregnancy
- prior surgery in the infraclavicular region
- chronic pain syndromes requiring opioid intake at home


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Infraclavicular block Duration of motor blockade Intravenous dexamethasone Perineural dexamethasone

Intervention(s)

Patients will receive 5 mg of dexamethasone intravenously.,Patients will receive the injectate with 5 mg of dexamethasone through the block needle.

Intravenous dexamethasone,Perineural dexamethasone

Experimental Drug,Experimental Drug

Primary Outcome(s)

Duration of the motor block within 48 hours the interval between the end of LA injection and the return of movement to hand and fingers

Secondary Outcome(s)

Duration of the sensory block within 48 hours the interval between the end of LA injection and the return of sensation to the hand and fingers,Duration of the analgesia within 48 hours the interval between the end of LA injection and the appearance of pain at the surgical site,Sensory blockade of the musculocutaneous, median, radial and ulnar nerves every 5 minutes until 30 minutes after the procedure a 3-point scale using a cold test: 0 = no block, 1 = analgesia, 2 = anesthesia,Motor blockade of the musculocutaneous, median, radial and ulnar nerves every 5 minutes until 30 minutes after the procedure a 3-point scale: 0 = no block, 1 = paresis, 2 = paralysis ,Success rate for surgical anesthesia at the beginning of the surgery the ability to proceed with surgery without the need for IV narcotics, GA, or LA infiltration,Onset time until 30 minutes after the procedure the time required to reach a minimal score of 14 out of 16 points.,Persistent sensory or motor deficits 7 days after the prpcedure all patients will be contacted by phone,Complications during the procedure and perioperative period vascular puncture, hematoma at the puncture site , toxic effects of LA, hoarseness, Horner syndrome

Secondary ID(s)

ID 05-58-22

Source(s) of Monetary Support

No source of support

Secondary Sponsor(s)

No sponsor

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Prof. Pratak O-Prasertsawat

662-201-1000 Ext.

Results

• Date Completed: 01/12/2015