Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

Anesthesia, Local Clinical Trial

Official title:

Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677778
• Other study ID #: 46830
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.

Exclusion criteria:

• Concomitant life-threatening injuries and other concomitant injuries causing significant pain
• Pregnant
• Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.

Related Conditions & MeSH terms

• Anesthesia, Local
• Arm Injuries
• Paralysis
• Phrenic Nerve Palsy on the Left
• Phrenic Nerve Palsy on the Right
• Phrenic Nerve Paralysis
• Upper Extremity Injury

Intervention

Procedure:
• Normal saline injected via interscalene nerve catheter
With the catheter covered, treatment group patients will receive a normal saline (NS) bolus regimen (30cc 0.9% NS) via their interscalene nerve block catheter.

Other:
• Placebo
With the catheter covered, placebo group patients will go through the same steps as the treatment group, but no solution will be injected into the interscalene nerve block catheter.

Locations

Country	Name	City	State
United States	Stanford Health Care (SHC)	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Courtney KR, Kendig JJ, Cohen EN. Frequency-dependent conduction block: the role of nerve impulse pattern in local anesthetic potency. Anesthesiology. 1978 Feb;48(2):111-7. — View Citation

Ip VH, Tsui BC. Continuous interscalene block: the good, the bad and the refined spread. Acta Anaesthesiol Scand. 2012 Apr;56(4):526-30. doi: 10.1111/j.1399-6576.2012.02650.x. Epub 2012 Feb 16. — View Citation

Katircioglu K, Ozkalkanli MY, Kalfaoglu H, Sannav S, Ozgurbuz U, Savaci S. Reversal of prilocaine epidural anesthesia using epidural saline or ringer's lactate washout. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):389-92. — View Citation

Lenters TR, Davies J, Matsen FA 3rd. The types and severity of complications associated with interscalene brachial plexus block anesthesia: local and national evidence. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):379-87. Epub 2007 Apr 19. — View Citation

Park EY, Kil HK, Park WS, Lee NH, Hong JY. Effect of epidural saline washout on regression of sensory and motor block after epidural anaesthesia with 2% lidocaine and fentanyl in elderly patients. Anaesthesia. 2009 Mar;64(3):273-6. doi: 10.1111/j.1365-2044.2008.05746.x. — View Citation

Sitzman BT, DiFazio CA, Playfair PA, Stevens RA, Hanes CF, Herman TB, Yates HK, Leisure GS. Reversal of lidocaine with epinephrine epidural anesthesia using epidural saline washout. Reg Anesth Pain Med. 2001 May-Jun;26(3):246-51. — View Citation

Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. — View Citation

Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. — View Citation

Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forced vital capacity (FVC)	Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.	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)
Primary	Change in peak expiratory flow (PEF)	Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.	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)
Primary	Change in forced expiratory volume in 1 second (FEV1)	Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.	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)
Secondary	Diaphragmatic excursion	Diaphragmatic excursion will be assessed via ultrasound before nerve block is placed, after surgery, and while receiving either the placebo or treatment.	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.)
Secondary	Brachial plexus sensory and motor exam	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.	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).
Secondary	Pain scores	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.	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)