Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

NCT03677778 | Completed

• 1 other identifier: 46830
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Phrenic Nerve Paralysis; Upper Extremity Injury; Phrenic Nerve Palsy on the Left; Phrenic Nerve Palsy on the Right

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• 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.)

• 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).

• 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)

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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.

Other: Placebo

Treatment group

ACTIVE COMPARATOR

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.

Procedure: Normal saline injected via interscalene nerve catheter

Interventions

Normal saline injected via interscalene nerve catheter PROCEDURE

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.

Treatment group

Placebo OTHER

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care (SHC)

Palo Alto, California, 94304, United States

Location

Related Publications (10)

• 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. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• 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. doi: 10.1213/00000539-199203000-00006.

  PMID: 1539813 BACKGROUND

• 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. doi: 10.1016/j.jse.2006.10.007. Epub 2007 Apr 19.

  PMID: 17448698 BACKGROUND

• Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.

  PMID: 15305253 BACKGROUND

• 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. doi: 10.1016/j.rapm.2007.06.004.

  PMID: 17961836 BACKGROUND

• 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.

  PMID: 19302639 BACKGROUND

• 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. doi: 10.1053/rapm.2001.22587.

  PMID: 11359224 BACKGROUND

• 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.

  PMID: 22338616 BACKGROUND

• 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. No abstract available.

  PMID: 306789 BACKGROUND

• Gerber LN, Sun LY, Ma W, Basireddy S, Guo N, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BC. Clinical effect of normal saline injectate into interscalene nerve block catheters given within one hour of local anesthetic bolus on analgesia and hemidiaphragmatic paralysis. Reg Anesth Pain Med. 2021 Feb;46(2):124-129. doi: 10.1136/rapm-2020-101922. Epub 2020 Nov 12.

  PMID: 33184166 DERIVED

MeSH Terms

Conditions

Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ban Tsui, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: October 22, 2018
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)