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

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ClinicalTrials.gov Identifier: NCT02433561
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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.


Condition or disease Intervention/treatment Phase
Shoulder Pain Regional Anesthesia Morbidity Shoulder Arthritis Procedure: Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) Procedure: Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block: Respiratory-related and Pain-related Outcomes
Study Start Date : November 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Active Comparator: Intraplexic catheter
Intraplexic approach (Patients will have the catheter placed within the plexus, classical approach)
Procedure: Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)
The catheter tip will be placed with the aid of the ultrasound within the brachial plexus between C5 and C6
Other Name: Contiplex® C, B. Braun Melsungen, AG

Experimental: Extraplexic catheter
Extraplexic approach (Patients will have the catheter placed out of the plexus.)
Procedure: Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)
The catheter tip will be placed with the aid of the ultrasound 2 mm away from the lateral part of the brachial plexus
Other Name: Contiplex® C, B. Braun Melsungen, AG




Primary Outcome Measures :
  1. Rate of hemidiaphragmatic paresis [ Time Frame: 24 postoperative hours ]

Secondary Outcome Measures :
  1. Fentanyl consumption [ Time Frame: Intraoperative ]
  2. Morphine consumption [ Time Frame: 2 postoperative hours ]
  3. Oxycodone consumption [ Time Frame: postoperative day 1, 2 and 3 ]
  4. Pain scores at rest [ Time Frame: postoperative day 1, 2 and 3 ]
  5. Pain scores on movement [ Time Frame: postoperative day 1, 2 and 3 ]
  6. Forced expiratory volume at 1 sec (FEV1) [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  7. Forced vital capacity [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  8. Peak expiratory flow [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  9. Rate of hemidiaphragmatic paresis [ Time Frame: postoperative day 0, 2 and 3 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433561


Locations
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Switzerland
Eric Albrecht
Lausanne, Vaud, Switzerland, 1004
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
B. Braun Melsungen AG
Investigators
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Principal Investigator: Eric Albrecht, MD Centre Hospitalier Universitaire Vaudois
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Albrecht, PD Dr Eric Albrecht, MD, MER, DESA, Program Director, Regional Anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02433561    
Other Study ID Numbers: CHUVaudois
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Arthralgia
Pain
Neurologic Manifestations