A Randomized Comparison Between 2, 5 and 8 mg of Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block

• Register: TCTR
• Last refreshed on: 1 April 2024
• Main ID: TCTR20170720001
• Date of registration: 20/07/2017
• Prospective Registration: Yes
• Primary sponsor: None
• Public title: A Randomized Comparison Between 2, 5 and 8 mg of Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block
• Scientific title: A Randomized Comparison Between 2, 5 and 8 mg of Perineural Dexamethasone for Ultrasound-Guided Infraclavicular Block
• Date of first enrolment: 22/07/2017
• Target sample size: 360
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170720001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Contacts

• Name: Vanlapa Arnuntasupakul
• Affiliation: Mahidol University

• Name: De Q Tran
• Affiliation: McGill University

Key inclusion & exclusion criteria

Inclusion criteria: - Patients undergoing upper extremity surgery (elbow and below).
- American Society of Anesthesiologists classification 1 to 3
- Body mass index between 18 and 35 kg/m2
Exclusion criteria: - pre existing neuropathy or coagulopathy
- renal failure or hepatic failure
- allergy to local anesthetics
- pregnancy
- prior surgery in the area of the infraclavicular fossa
- 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

Anesthesia
Analgesia

Regional anesthesia Infraclavicular brachial plexus block
Anesthesia
Analgesia

Intervention(s)

Active Comparator Drug,Active Comparator Drug,Active Comparator Drug

2 mg of perineural dexamethasone,5 mg of perineural dexamethasone,8 mg of perineural dexamethasone

The single-injection perivascular infraclavicular block will be performed using 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 mcg/mL and 2 mg of dexamethasone.,The single-injection perivascular infraclavicular block will be performed using 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 mcg/mL and 5 mg of dexamethasone.,The single-injection perivascular infraclavicular block will be performed using 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 mcg/mL and 8 mg of dexamethasone.

Primary Outcome(s)

Duration of motor blockade within 24 hours after the end of the procedure Record time from the end of local anesthetic injection and return of movement of hand and fingers

Secondary Outcome(s)

Duration of sensory blockade within 24 hours after the end of the procedure Record time from the end of local anesthetic injection and return of sensation of hand and fingers,Duration of analgesia within 24 hours after the end of the procedure Record the time from the end of local anesthetic injection and appearance of pain at surgical site,Success rate for surgical anesthesia within 2 hours after the end of the procedure Record the ability to proceed with surgery without the need for general anesthesia and rescue blocks,Complications within 60 minutes after the end of the procedure Record incidences of intravascular injection, systemic toxic, hematoma,Onset time within 30 minutes after the end of the procedure Record the time required to reach a minimal score of 14 out of 16 points,Performance time within 20 minutes after starting the procedure Record the time from applying ultrasound probe on skin to the end of local anesthetic drug injection,Number of needle passes during the procedure Record number of needle passes used to reach the target,Procedural pain at the end of the procedure Record pain during the procedure using visual analog scale from 0 to 10,Success rate of the procedure at 30 minutes after the end of the procedure Record the proportion of blocks with a minimal composition score of 14 out of 16 points

Source(s) of Monetary Support

None

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Results

• Date Completed: 19/06/2018