Nerve Block Washout

NCT02050295 | Terminated

• 1 other identifier: Pro00044120
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Injecting local anesthetic to anesthetize a nerve or group of nerves (a 'nerve block') is an effective way to eliminate pain during and after surgery. There are instances when it would be beneficial to the patient for the nerve block to be resolved quickly rather than waiting for it to naturally wear off. For example, a sciatic nerve block that freezes the lower leg and foot typically takes over 18 hours to resolve on its own, and both the surgeon and patient prefer to have motor function before discharge. The investigators wish to perform a randomized, controlled trial to determine if infusion of a solution such as saline to 'wash out' the nerve block after surgery can allow the patient to be pain-free while still being able to move their leg and foot.

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Motor function

  Motor function (dorsiflexion and plantar flexion) in the absence of pain will be assessed in the period 72 hours following surgery or discharge from hospital, whichever comes first.

  Within 72 hours post-surgery

Secondary Outcomes (4)

• Sensory function

  Within 72 hours post-surgery

• Pain

  Within 72 hours post-surgery

• Patient satisfaction

  Within 72 hours post-surgery

• Time to first oral analgesic

  Within 72 hours post-surgery

Study Arms (2)

Nerve block washout

EXPERIMENTAL

Patients will receive a washout infusion of saline through their perineural catheter to reverse their motor block while maintaining the sensory block.

Procedure: Nerve block washout; Drug: Saline

Sham washout

SHAM COMPARATOR

Patients will receive an infusion of saline run just enough to maintain catheter patency.

Procedure: Sham washout; Drug: Saline

Interventions

Nerve block washout PROCEDURE

Saline will be infused through the perineural catheter to reverse motor block.

Nerve block washout

Sham washout PROCEDURE

Infusion of saline to maintain catheter patency.

Sham washout

Saline DRUG

Also known as: Normal saline, Saline 0.9%

Nerve block washout; Sham washout

Eligibility Criteria

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

You may qualify if:

• Provide informed written consent
• Adult (≥ 18 years old) patients
• Scheduled for lower extremity surgery wholly or partially under popliteal sciatic nerve block

You may not qualify if:

• Failure to provide informed consent
• Infection at the needle insertion site
• Known coagulopathy
• Known allergy to local anesthetics
• Presence of sensory or motor impairment in the distribution of the sciatic nerve prior to nerve blockade
• Inability to perform valid sensory or motor examination of the function of the sciatic nerve prior to nerve blockade due to impaired access to the limb, language barrier, or inability of the subject to co-operate with such examination

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (6)

• 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

• 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

• Taboada Muniz M, aLvarez J, Cortes J, Rodrguez J, Atanassoff PG. Lateral approach to the sciatic nerve block in the popliteal fossa: correlation between evoked motor response and sensory block. Reg Anesth Pain Med. 2003 Sep-Oct;28(5):450-5. doi: 10.1016/j.rapm.2003.08.007.

  PMID: 14556137 BACKGROUND

• Tsui BCH, Malherbe S, Koller J, Aronyk K. Reversal of an unintentional spinal anesthetic by cerebrospinal lavage. Anesth Analg. 2004 Feb;98(2):434-436. doi: 10.1213/01.ANE.0000095152.81728.DC.

  PMID: 14742383 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)