Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block
This study is currently recruiting participants.
Verified January 2013 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Ariane Boivin
Information provided by (Responsible Party):
Ariane Boivin, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01761175
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Anesthesia |
Procedure: Ultrasound-guided infraclavicular block Procedure: Ultrasound-guided axillary block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Prospective Randomized Blinded Controlled Study |
Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Primary Outcome Measures:
- Number of patients with complete sensory block [ Time Frame: 30 minutes after block completion ] [ Designated as safety issue: No ]Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
Secondary Outcome Measures:
- Number of patients with complete motor blocks [ Time Frame: 30 minutes after block completion ] [ Designated as safety issue: No ]Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
- Time to complete sensory and motor blocks. [ Time Frame: 0, 5, 10, 15, 20, 25 and 30 minutes after block completion ] [ Designated as safety issue: No ]Sensory and motor blocks are evaluated in the median, ulnar, radial and musculocutaneous nerves territories.
- Procedure-related pain on a visual analog pain scale [ Time Frame: During the nerve block procedure ] [ Designated as safety issue: No ]
- Number of patients with adverse events related to nerve block [ Time Frame: 24 hours and 1 month after surgery ] [ Designated as safety issue: Yes ]
- Surgical block success rate [ Time Frame: End of surgery ] [ Designated as safety issue: No ]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.
- Performance time of the nerve block [ Time Frame: During the performance of the block ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 224 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761175
Contacts
| Contact: Ariane Boivin, MD | ariane.boivin.2@ulaval.ca |
Locations
| Canada, Quebec | |
| Hôpital de l'Enfant-Jésus | Recruiting |
| Québec, Quebec, Canada, G1J 1Z4 | |
| Contact: Ariane Boivin, MD ariane.boivin.2@ulaval.ca | |
| Principal Investigator: Ariane Boivin, Md | |
| Hôpital de Saint-Sacrement | Recruiting |
| Québec, Quebec, Canada, G1S 4L8 | |
| Contact: Ariane Boivin, MD ariane.boivin.2@ulaval.ca | |
| Principal Investigator: Ariane Boivin, Md | |
Sponsors and Collaborators
Ariane Boivin
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
No publications provided
| Responsible Party: | Ariane Boivin, MD, Centre Hospitalier Universitaire de Québec, CHU de Québec |
| ClinicalTrials.gov Identifier: | NCT01761175 History of Changes |
| Other Study ID Numbers: | PEJ-666 |
| Study First Received: | January 3, 2013 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
ClinicalTrials.gov processed this record on May 16, 2013