Pain Management, Pain Syndrome
Conditions
Keywords
peripheral nerve block, neurostimulation
Brief summary
Peripheral nerve blocks are routinely used and highly successful for intra-operative anesthesia and post-operative pain management. Nerve blocks are guided using either neurostimulation as a means to localize the right nerve or by ultrasound guidance or combining the 2 methods. The purpose of this study is to assess whether electrical stimulation improves nerve block quality, beyond its simple purpose of nerve localization.
Detailed description
The investigators wish to understand how electrical stimulation can affect local anesthetic disposition when performing a peripheral nerve block. By studying this subject, the investigators open possibilities for improvement on many levels: increasing the efficacy of the nerve block allows for a reduced onset time, reduced incidence of incomplete block and prolonged duration of the local anesthetics. This allows for patients to fully benefit from the analgesic properties of the nerve block, allows for a decrease in delays for the operating room readiness, and a decrease in the amount of medication needed for a successful nerve block. This will decrease side effects and risks of the nerve blocks. Overall better post-surgical pain control may decrease risks for developing chronic post-operative pain, a major post-operative complication. The results of this study will open the door to novel approaches to manage acute post-operative pain.
Interventions
DEVICEB Braun HNS 12 nerve stimulator
Nerve stimulator that is traditionally used for nerve localization during block placements.
DEVICEB Braun HNS 12 nerve stimulator sham control
Stimulator will be placed and turned on, but the grounding electrode will not be connected to prevent nerve stimulation.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing elective upper limb surgery with a planned brachial plexus nerve block
Exclusion criteria
* Under 18 years old * ASA score above III * Chronic pain condition with daily milligrams of morphine equivalent \> 30 * Poorly controlled psychiatric condition * Coagulopathy * Active infection * Moderate, severe or progressing neuropathy * COPD/Chronic oxygen user * Pregnancy * Incarceration * Unable to consent * BMI \> 35 * Pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of sensory and motor block | Within 1 hour after the block placement | Determining time when patient experience first symptoms of local anesthetic action on the upper trunk distribution (median or musculo cutaneous nerve) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of motor block | Within 1 hour after the block placement | Determining time when patient start loosing strength at the musculo cutaneous nerve (biceps brichialis muscle) |
| Duration of sensory block | up to 7 days after surgery | Time after surgery at which the patient recovers first sign of sensory function |
| duration of motor block | up to 7 days after surgery | Time after surgery at which the patient recovers a biceps brachialis function |
| When patient experience first pain | up to day 7 post operatively | Time after surgery at which the patient experience first sign of pain at the surgical site |
| Time of first opioid taken | within the first 7 days after surgery | When the first opioid was taken |
| Opioid usage at day 1 | at post operative day 1 | Milligram of morphine equivalent |
| opioid usage assessment at day 7 | Within the Post operative day 1 and 7 | Milligram of morphine equivalent taken |
| Opioid usage assessment at day 28 | usage between post operative day 7 and 28 | milligram of morphine equivalent assess at day 28 |
| Last opioid usage after day 28 | Assessment within 1 year | When was the last day of opioid usage |
| Patient satisfaction | At Post Operative day 7, 28 and 1 year | Assessing patient's satisfaction, using the standardized -Quality of Recovery 15- at post operative day 7, 28 and 1 year. Each item count on a 0-10 scale where O is worse and 10 is best PART A How have you been feeling in the last 24 hours? (0 to 10, where 0 = none of the time \[poor\] and 10 = all of the time \[excellent\] Q.1 Able to breathe easily Q.2 Been able to enjoy food Q.3 Feeling rested Q.4 Have had a good sleep Q.5 Able to look after personal toilet and hygiene unaided Q.6 Able to communicate with family or friends Q.7 Getting support from hospital doctors and nurses Q.8 Able to return to work or usual home activities Q.9 Feeling comfortable and in control Q.10 Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Q.11 Moderate pain Q.12 Severe pain Q.13 Nausea or vomiting Q.14 Feeling worried or anxious Q.15 Feeling sad or depressed |
| Amount of opioid usage after 28 days | 28 days to 1 year after surgery | Milligram of morphine equivalent use weekly after 28 days |
| General satisfaction | at post operative day 7, 28 and 1 year | General satisfaction on a scale from 1-5 (extremely unsatisfied, unsatisfied, neutral, satisfy, extremely satisfied) |
Countries
United States
Outcome results
None listed