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

• ClinicalTrials.gov Identifier: NCT01761175
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Sponsor: CHU de Quebec-Universite Laval
• Information provided by (Responsible Party): Ariane Boivin, CHU de Quebec-Universite Laval

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Procedure: Ultrasound-guided infraclavicular block; Procedure: Ultrasound-guided axillary block	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
• Study Start Date: September 2012
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ultrasound-guided infraclavicular block; Ultrasound-guided single injection infraclavicular block	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.
Active Comparator: Ultrasound-guided axillary block; Ultrasound-guided double injection axillary block	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Complete Sensory Block [ Time Frame: 30 minutes after block completion ]
   Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.

Secondary Outcome Measures :

1. Number of Patients With Complete Motor Blocks [ Time Frame: 30 minutes after block completion ]
   Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
2. Time to Complete Sensory Block. [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes after block completion ]
   Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
3. Time to Complete Motor Block [ Time Frame: 5, 10, 15, 20, 25 and 30 minutes after block completion ]
   Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
4. Surgical Block Success Rate [ Time Frame: End of surgery ]
   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.
5. Performance Time of the Nerve Block [ Time Frame: During the performance of the 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).
6. Procedure-related Pain on a Visual Analog Pain Scale [ Time Frame: After the nerve block procedure ended, up to 5 minutes. ]
   Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).
7. Number of Patients With Postoperative Adverse Events Related to Nerve Block [ Time Frame: 24 hours after surgery ]
   Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
8. Number of Patients With Postoperative Adverse Events Related to Nerve Block [ Time Frame: 1 month after surgery ]
   Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.
9. Duration of Surgery [ Time Frame: The end of surgery ]
10. Tourniquet Use [ Time Frame: The end of surgery ]
    Number of participants who had a tourniquet during the surgery
11. Duration of Tourniquet [ Time Frame: The end of surgery ]
    The total time the tourniquet was left inflated

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada

Hôpital de l'Enfant-Jésus

Québec, Canada, G1J 1Z4

Hôpital de Saint-Sacrement

Québec, Canada, G1S 4L8

Sponsors and Collaborators

CHU de Quebec-Universite Laval

Investigators

• Principal Investigator: Ariane Boivin, MD; CHU de Québec
• Principal Investigator: Marie-Josée Nadeau, MD; CHU de Québec
• Principal Investigator: Nicolas Dion, MD; CHU de Québec
• Principal Investigator: Simon Lévesque, MD; CHU de Québec
• Principal Investigator: Pierre C. Nicole, MD; CHU de Québec
• Principal Investigator: Alexis F. Turgeon, MD, Msc; CHU de Québec

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Boivin A, Nadeau MJ, Dion N, Lévesque S, Nicole PC, Turgeon AF. Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial. Anesth Analg. 2016 Jan;122(1):273-8. doi: 10.1213/ANE.0000000000001017.

• Responsible Party: Ariane Boivin, MD, CHU de Quebec-Universite Laval
• ClinicalTrials.gov Identifier: NCT01761175 History of Changes
• Other Study ID Numbers: PEJ-666
• First Posted: January 4, 2013
• Results First Posted: August 4, 2017
• Last Update Posted: August 4, 2017
• Last Verified: April 2017