Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
- Conditions
- Upper Extremity InjuryPhrenic Nerve Palsy on the LeftAnesthesia, LocalPhrenic Nerve ParalysisPhrenic Nerve Palsy on the Right
- Interventions
- Other: PlaceboProcedure: Normal saline injected via interscalene nerve catheter
- Registration Number
- NCT03677778
- Lead Sponsor
- Stanford University
- Brief Summary
One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.
The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This control group will have no normal saline injected into their nerve catheter (no intervention). Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group. Treatment group Normal saline injected via interscalene nerve catheter After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This group will then have 30ml of normal saline injected into their nerve catheter. Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group.
- Primary Outcome Measures
Name Time Method Change in forced vital capacity (FVC) Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments) Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in peak expiratory flow (PEF) Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments) Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in forced expiratory volume in 1 second (FEV1) Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments) Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
- Secondary Outcome Measures
Name Time Method Pain scores Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments) The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Pain scores will be assessed before nerve block is placed, after surgery, while receiving either the placebo or treatment.
Brachial plexus sensory and motor exam Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments). Brachial plexus sensory and motor exam changes will be assessed before nerve block is placed, after surgery, and while receiving either the placebo or treatment.
Diaphragmatic excursion Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.) Diaphragmatic excursion will be assessed via ultrasound before nerve block is placed, after surgery, and while receiving either the placebo or treatment.
Trial Locations
- Locations (1)
Stanford Health Care (SHC)
🇺🇸Palo Alto, California, United States