Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block

NCT02433561 | Completed Phase 4

• 1 other identifier: CHUVaudois
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous interscalene brachial plexus block consists of inserting a catheter directly within the brachial plexus in the interscalene groove, between the middle and anterior scalene muscles, which is then infused with local anesthetic. This technique provides potent and site-specific analgesia for several days after major shoulder surgery, along with increased shoulder range of motion. A major side-effect of this procedure is the paralysis of the ipsilateral diaphragm, which is the main muscle of the respiration. This paralysis occurs at a rate of 90 to 100%, and is due to the spread of the local anesthetic towards the phrenic nerve, lying anteriorly to the plexus, between the sternocleidomastoid and anterior scalene muscles. Therefore, many patients suffering from respiratory syndromes, such as chronic obstructive pulmonary disease, will not have a continuous interscalene brachial plexus block, thus forfeiting some, or all, of the aforementioned benefits associated regional anesthesia. It is conventionally taught to place the needle tip between the nerve roots of the brachial plexus to obtain an effective block (intra-plexic injection). Recently, we have published a new technique of single-shot injection for interscalene brachial plexus block where the needle tip was positioned at a distance of 4 mm of the lateral part of the brachial plexus (extra-plexic injection) and resulted in a reduction rate of 70% of hemidiaphragmatic paresis and a preservation of spirometric values, while providing similar analgesia, when compared to a conventional injection. Contrary to single-shot injections where high volume and high concentration of local anesthetics are injected (eg, ropivacaine 0.5%, 20 mLs), continuous blocks required low volume and low concentration (eg, ropivacaine 0.1-2%, 2-6 mLs/h) and therefore the aforementioned concept of extra-plexic technique might not be suitable. Recently, new catheter-over-the needle (Contiplex® C; B. Braun Melsungen AG, Germany) have been released on the market and allows the physician to place the catheter tip exactly where he desires, contrary to the previous generations where the catheters were inserted blindly, despite the use of ultrasound. The first objective of that randomised controlled trial is to demonstrate that an extra-plexus catheter placement produces less respiratory complications than an intra-plexus catheter placement. The second objective is to confirm that both techniques provide similar analgesia.

Conditions

Shoulder Pain; Regional Anesthesia Morbidity; Shoulder Arthritis

Outcome Measures

Primary Outcomes (1)

• Rate of hemidiaphragmatic paresis

  24 postoperative hours

Secondary Outcomes (9)

• Fentanyl consumption

  Intraoperative

• Morphine consumption

  2 postoperative hours

• Oxycodone consumption

  postoperative day 1, 2 and 3

• Pain scores at rest

  postoperative day 1, 2 and 3

• Pain scores on movement

  postoperative day 1, 2 and 3

Study Arms (2)

Intraplexic catheter

ACTIVE COMPARATOR

Intraplexic approach (Patients will have the catheter placed within the plexus, classical approach)

Procedure: Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)

Extraplexic catheter

EXPERIMENTAL

Extraplexic approach (Patients will have the catheter placed out of the plexus.)

Procedure: Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)

Interventions

Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) PROCEDURE

The catheter tip will be placed with the aid of the ultrasound within the brachial plexus between C5 and C6

Also known as: Contiplex® C, B. Braun Melsungen, AG

Intraplexic catheter

Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) PROCEDURE

The catheter tip will be placed with the aid of the ultrasound 2 mm away from the lateral part of the brachial plexus

Also known as: Contiplex® C, B. Braun Melsungen, AG

Extraplexic catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• Major shoulder surgery: rotator cuff repair, shoulder arthroplasty

You may not qualify if:

• contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area);
• existing neurological deficit in the area to be blocked;
• history of neck surgery or radiotherapy;
• severe respiratory disease;
• chest deformity,
• pregnancy;
• inability to understand the informed consent and demands of the study;
• patient refusal.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• B. Braun Melsungen AG: collaborator

Study Sites (1)

Eric Albrecht

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (1)

• Albrecht E, Bathory I, Fournier N, Jacot-Guillarmod A, Farron A, Brull R. Reduced hemidiaphragmatic paresis with extrafascial compared with conventional intrafascial tip placement for continuous interscalene brachial plexus block: a randomized, controlled, double-blind trial. Br J Anaesth. 2017 Apr 1;118(4):586-592. doi: 10.1093/bja/aex050.

  PMID: 28403412 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Albrecht, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr Eric Albrecht, MD, MER, DESA, Program Director, Regional Anaesthesia

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: May 5, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11

Locations

CH (1)