Describe Novel Approach to Brachial Plexus Anesthesia Clinical Trial
Official title:
Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study
| Verified date | August 2013 |
| Source | Université de Sherbrooke |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Canadian Institutes of Health Research |
| Study type | Interventional |
The goal of this study is to demonstrate that the novel retroclavicular approach is a safe, fast and effective technique for ultrasound-guided brachial plexus anesthesia.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Elective or Urgent Surgery of the hand, wrist or forearm - 18 years and older - Ability to consent - American Society of Anesthesiologists class 1 to 3 Exclusion Criteria: - Infection at the site of infection - Abnormal anatomy at the site of infection - Coagulopathy - Severe Pulmonary Disease - Preexisting neurological symptom(s) in the operated arm - Pregnant patients - Patients weighing less than 50 kg - Allergy to amide type local anesthetics |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Université de Sherbrooke |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success Rate of the Block | Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand. | Assessed 30 minutes after block completion | No |
| Secondary | Surgical success rate | Success rate is defined as avoidance of rescue analgesic technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Data presented will be the need or not of a rescue analgesic technique | Defined at the beginning of surgery until the end of surgery | No |
| Secondary | Technique duration | Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal (local skin anesthesia plus injection of mepivacaine) | Time required in seconds for the retroclavicular block technique completion, assessed during block performance | No |
| Secondary | Needle visualization | Using the Likert standardized scale, two evaluators will individually quantify the ease of needle visualization using the video footage recorded by the ultrasound machine from all the retroclavicular blocks. Likert scale for visualization, is defined as: 1:very bad, 2: bad, 3: adequate, 4:good, 5: very good. No units are attached to this scale | Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion | No |
| Secondary | Patient discomfort | Using a Visual Analog Scale (VAS), patients will quantify the discomfort they experienced during the block. This assessment will take place in the minutes following mepivacaine injection and block needle withdrawal. The VAS scale is rated from 1-10, 1 being almost no pain and 10 being the worst pain ever. Assessment will be done by an independent person, not taking part in the study. The VAS has no units attached to it. |
Assessed immediately after the block | No |
| Secondary | Patient satisfaction | Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period. | Assessed 48 hours after the block | No |
| Secondary | Sensitive Block Progression | Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion (mepivacaine injection). The scale used is: 0:no sensitive block, 1:analgesia, 2:anesthesia. No units are attached to this scale. | Assessed 10, 20, 30 minutes after the block | No |
| Secondary | Motor Block Progression | Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion (mepivacaine injection). The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale | Assessed 10, 20, 30 minutes after the block | No |
| Secondary | Complication Rate | With a phone call to the patient at 48 hours after injection of mepivacaine, complications will be searched for (pain at puncture site, paresthesia or paresis in the operated arm, signs of infection at puncture site such as redness or purulent discharge). Response is classified as YES or NO. No units attached to this scale. If patient reports paresthesia or paresis, further questioning over the phone will determine which nerve or cord is involved. | Assessed 48 hours after the block | Yes |
| Secondary | Duration of the Block's Effects | Duration of the block will be evaluated using 3 criteria: patient's subjective opinion of when the block receded (time of the day), time at which first oral analgesia is taken, and time of first onset of pain. Units involved is time (for example "3 pm".) | Assessed 48 hours after the block | No |
| Secondary | Use of narcotic for tourniquet pain | If at any point during the surgery, patient complains of tourniquet pain, this will be noted as well as the analgesia given. Units is time of pain ("3 pm") and analgesia given ("micrograms of fentanyl"). | Assessed throughout the surgery | No |
| Secondary | Rate of Neurostimulation Usage | At the discretion of the anesthesiologist performing the block, neurostimulation can be used to supplement ultrasound guidance. This will be recorded as a YES or NO (neurostimulation used or not). No units attached to this rate. | Assessed during the block | No |