Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

NCT02893228 | Completed Phase 4

• 1 other identifier: AMNCH-A-SIPPIB
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an interscalene block the incidence of phrenic palsy will be reduced.

Conditions

Phrenic Nerve Palsy

Keywords

forced expiratory volume in 1 second; forced vital capacity; peak expiratory flow rate; interscalene block; diaphragmatic paresis

Outcome Measures

Primary Outcomes (1)

• Rate of diaphragmatic paresis recorded in the post-operative period identified by ultrasound assessment

  Diaphragmatic paresis will be documented with greater than 75% reduction in excursion compared to baseline

  4 hours

Secondary Outcomes (4)

• FEV1

  4 hours

• FVC

  4 hours

• PEFR

  4 hours

• Pain control

  24 hours post-opertive

Other Outcomes (1)

• Patient satisfaction

  4 hours

Study Arms (2)

Group S (saline group)

EXPERIMENTAL

In plane posterior approach will be used with a 50mm short bevel block needle (Braun), advanced through the middle scalene muscle. At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected. This will be followed by repositioning of the needle between roots C5 and C6 where 20 ml of 0.25% levobupivicaine will be injected in 5ml increments with intermittent aspiration.

Procedure: Saline; Drug: Levobupivacaine

Group C (control group)

ACTIVE COMPARATOR

In plane posterior approach will be used with a 50mm short bevel block needle (Braun), advanced through the middle scalene muscle. The needle tip will be positioned between roots C5 and C6 where 20 ml of 0.25% levobupivicaine will be injected in 5ml increments with intermittent aspiration.

Drug: Levobupivacaine

Interventions

Saline PROCEDURE

At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected.

Group S (saline group)

Levobupivacaine DRUG

the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia

Group C (control group); Group S (saline group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surgery on shoulder, humerus, or clavicle

You may not qualify if:

• Patient refusal
• Allergy to local anaesthesia
• Severe coagulopathy
• Contralateral phrenic nerve palsy
• Local infection
• Moderate to severe pulmonary dysfunction (GOLD II, II, IV)

Sponsors & Collaborators

• The Adelaide and Meath Hospital, incorporating The National Children's Hospital: lead

Study Sites (1)

Adelaide and Meath Hospital, Incorporating National Children Hospital

Tallagh, Dublin 24, Ireland

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, Grossi P, Sharrock NE, Stanton J, Gloeggler PJ. Digital pressure during interscalene block is clinically ineffective in preventing anesthetic spread to the cervical plexus. Anesth Analg. 1996 Aug;83(2):366-70. doi: 10.1097/00000539-199608000-00028.

  PMID: 8694320 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

• Cangiani LH, Rezende LA, Giancoli Neto A. Phrenic nerve block after interscalene brachial plexus block. Case report. Rev Bras Anestesiol. 2008 Mar-Apr;58(2):152-9. doi: 10.1590/s0034-70942008000200007. English, Portuguese.

  PMID: 19378533 BACKGROUND

• Rau RH, Chan YL, Chuang HI, Cheng CR, Wong KL, Wu KH, Wei TT. Dyspnea resulting from phrenic nerve paralysis after interscalene brachial plexus block in an obese male--a case report. Acta Anaesthesiol Sin. 1997 Jun;35(2):113-8.

  PMID: 9293653 BACKGROUND

• Wennike N, Thompson A. Interscalene block as a precipitant of respiratory dysfunction. Br J Hosp Med (Lond). 2012 Apr;73(4):227. doi: 10.12968/hmed.2012.73.4.227. No abstract available.

  PMID: 22585200 BACKGROUND

• Sinha SK, Abrams JH, Barnett JT, Muller JG, Lahiri B, Bernstein BA, Weller RS. Decreasing the local anesthetic volume from 20 to 10 mL for ultrasound-guided interscalene block at the cricoid level does not reduce the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):17-20. doi: 10.1097/aap.0b013e3182030648.

  PMID: 21751435 BACKGROUND

• Lee JH, Cho SH, Kim SH, Chae WS, Jin HC, Lee JS, Kim YI. Ropivacaine for ultrasound-guided interscalene block: 5 mL provides similar analgesia but less phrenic nerve paralysis than 10 mL. Can J Anaesth. 2011 Nov;58(11):1001-6. doi: 10.1007/s12630-011-9568-5. Epub 2011 Aug 20.

  PMID: 21858614 BACKGROUND

• Palhais N, Brull R, Kern C, Jacot-Guillarmod A, Charmoy A, Farron A, Albrecht E. Extrafascial injection for interscalene brachial plexus block reduces respiratory complications compared with a conventional intrafascial injection: a randomized, controlled, double-blind trial. Br J Anaesth. 2016 Apr;116(4):531-7. doi: 10.1093/bja/aew028.

  PMID: 26994230 BACKGROUND

• Stundner O, Meissnitzer M, Brummett CM, Moser S, Forstner R, Kokofer A, Danninger T, Gerner P, Kirchmair L, Fritsch G. Comparison of tissue distribution, phrenic nerve involvement, and epidural spread in standard- vs low-volume ultrasound-guided interscalene plexus block using contrast magnetic resonance imaging: a randomized, controlled trial. Br J Anaesth. 2016 Mar;116(3):405-12. doi: 10.1093/bja/aev550.

  PMID: 26865133 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride; Levobupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Karthikeyan Srinivasan, MD., FCARCSI

  Adelaide and Meathe Hospital, Incorporating National Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)