Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block

Anesthesia Clinical Trial

Official title:

Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Prospective Randomized Blinded Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761175
• Other study ID #: PEJ-666
• Status: Completed
• Phase: N/A
• First received: January 3, 2013
• Last updated: February 9, 2014
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• American Society of Anesthesiologists Class 1 to 3

• Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia

Exclusion Criteria:

• Age less than 18 years

• Body mass index more than 40 kg/m2

• Weight less than 45 kg

• Patient refusal

• Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)

• Previous neurological deficit in the operated arm

• Severe renal or hepatic failure

• Prior surgery in the axillary or infraclavicular area

• Pregnancy or breast-feeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Ultrasound-guided infraclavicular block
Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery.
• Ultrasound-guided axillary block
Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve.

Locations

Country	Name	City	State
Canada	Hôpital de l'Enfant-Jésus	Québec	Quebec
Canada	Hôpital de Saint-Sacrement	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ariane Boivin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete sensory block	Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.	30 minutes after block completion	No
Secondary	Number of patients with complete motor blocks	Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.	30 minutes after block completion	No
Secondary	Time to complete sensory and motor blocks.	Sensory and motor blocks are evaluated in the median, ulnar, radial and musculocutaneous nerves territories.	0, 5, 10, 15, 20, 25 and 30 minutes after block completion	No
Secondary	Procedure-related pain on a visual analog pain scale		During the nerve block procedure	No
Secondary	Number of patients with adverse events related to nerve block		24 hours and 1 month after surgery	Yes
Secondary	Surgical block success rate	Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.	End of surgery	No
Secondary	Performance time of the nerve block	Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).	During the performance of the block	No