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Shoulder PainPhase 4NCT02433561

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

A Phase 4 study testing Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) and Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) in people with Shoulder Pain and Regional Anesthesia Morbidity, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) and Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSwitzerland
Study dates
Nov 2015to Oct 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Eric Albrecht

    Lausanne, Canton of Vaud, 1004

Other trials in Switzerland

About this study

Official title: Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block: Respiratory-related and Pain-related Outcomes

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.

Read more

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.

Read the detailed description

Patients will be brought to the block room theatre. Before nerve blockade, standard monitoring including non-invasive blood pressure, electrocardiogram, and pulse oximetry will be applied and IV access established. Sedation and anxiolysis will be achieved with IV midazolam (incremental doses of 1 mg) and IV fentanyl (incremental doses of 25 µg).

Continuous interscalene brachial plexus block will be performed with the patient lying lateral on the non-operative side. The ultrasound probe will be placed in the interscalene region to visualize the carotid artery and brachial plexus in the transverse sectional view as is routine in our institution. The C5-C6-C7 roots will be identified following the description of Martinolo et al. After sterilization and injection of local anesthetic (1-2% lidocaine) into the skin, a catheter-over-the-needle (Contiplex® C; B. Braun Melsungen AG, Germany) will be placed on the lateral side of the probe and advanced along the long axis of the probe in the same plane as the ultrasound beam. For patients in the intra-plexus group, the catheter tip will be positioned beyond the sheath, between C5 and C6 roots. In the extra-plexus group, the catheter tip will be positioned 2 mm away from the lateral sheath of the brachial plexus. After the injection of dose-test to exclude an intravascular placement, twenty milliliters of local anesthetic containing ropivacaine 0.5% will be injected over 3-5 min under ultrasound visualization.

Intraoperative and postoperative procedure After application of routine monitors in the operating theatre, patients will receive a standard general anesthetic. Anesthesia will be induced using fentanyl 1-2 µg/kg IV and propofol 2-4 mg/kg IV with endotracheal intubation facilitated by rocuronium 0.6 mg/kg IV. Maintenance of anesthesia will be ensured via inhaled sevoflurane 1.6-2.5% in a 40:60 mixture of oxygen and air. Positive pressure ventilation will be initiated with tidal volume and rate adjusted to maintain an end-tidal PCO2 of 30-40 mmHg. Fentanyl will be administered as needed to treat increases in blood pressure and/or heart rate of more than 15% above pre-induction baseline values. Prophylaxis of postoperative of nausea and vomiting will be performed with dexamethasone 0.15 mg/kg after the induction, droperidol 1 mg and ondansetron 4 mg at the end of the surgery, as per routine practice in our institution. Muscle relaxation will be antagonized with neostigmine 50 µg/kg and glycopyrrolate 5-10 µg/kg routinely.

During postoperative recovery in hospital, pain (Numeric rating scale [NRS] ≥ 4 or patient request for analgesia) will be treated with morphine 2 mg every 10 min as needed, and the ropivacaine 0.2% infusion will be set at a rate of 2 ml/h with bolus of 4 ml available every 30 minutes, as per our routine institutional practice. Once oral intake will be initiated, patients will receive acetaminophen 1000 mg PO every 6 h and breakthrough oxycodone 5 mg per os (PO) as needed, max 8 times. On the ward, infusion rate of ropivacaine will be increased to 4 ml/h and then 6 ml/h in case of pain scores ≥ 4. The catheter will be removed on the morning of postoperative day 3.

On postoperative day 1, 2, 3, and 4 a blinded research assistant will visit patients and record data. Patients will also be contacted on postoperative day 30 to capture any block-related complications such as persistent paresthesia, weakness, bruising, or non-surgical pain in the operative extremity.

All these managements represent the current standard of care at Centre Hospitalier Universitaire Vaudois.

Measurement of respiratory outcomes Diaphragmatic movement will be assessed by real-time M-mode ultrasonography on each side using a curvilinear 2 - 5 MHz US probe, following previous published descriptions. Patients will be examined in the lying position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. The range of diaphragmatic movement from the resting expiratory position (functional residual capacity) to deep and quiet inspiration (sigh test) will be recorded as will the range of diaphragmatic movement from resting expiratory position when quickly inspirating through the nose (sniff test). The movement of the diaphragm will be measured in centimeters.

  • diaphragmatic movement reduction of more than 75%, no movement, or paradoxical movement will be considered to be " complete paresis " ;
  • diaphragmatic movement reduction of both sigh and sniff test between 25% and 75% will be considered to be " partial paresis " ;
  • diaphragmatic movement of less than 25% will be considered to be " no paresis ".

Normal caudad movement will be designated as positive, whereas paradoxical cephalad movement will be designated as negative. Each test will performed 3 times, and values will be averaged. All measurements will be performed before the surgery (baseline), after the surgery in phase 1 recovery (postanesthetic care unit) and on postoperative day 1.

A bedside spirometer (EasyOneTM Spirometer; ndd Medical Technologies, Andover, UK) will be used to assess ventilatory function (pulmonary function tests). After instructions, the full vital capacity (VC) in lying and sitting upright positions will be measured. Other measurements performed in patients in upright sitting position will be forced expiratory volume at 1 sec (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF); the tests will be repeated 3 times. The best value will be recorded.

All measurements will be performed before the surgery (baseline), after the surgery in phase 1 recovery (postanesthetic care unit) and on postoperative day 1, 2, 3 and 4.

The percent fall of vital capacity from sitting to supine position will be considered as an index of diaphragmatic dysfunction.

Being tested
Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG), Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)Procedure or surgery

    Also called 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

  • Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)Procedure or surgery

    Also called 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

Study groups in NCT02433561
Study groupRoleWhat they receive
Intraplexic catheterActive comparatorIntraplexic approach (Patients will have the catheter placed within the plexus, classical approach)
Receives: Procedure: Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)
Extraplexic catheterExperimentalExtraplexic approach (Patients will have the catheter placed out of the plexus.)
Receives: Procedure: Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of hemidiaphragmatic paresis

    Measured: 24 postoperative hours

Secondary outcomes (9)
  1. Fentanyl consumption

    Measured: Intraoperative

  2. Morphine consumption

    Measured: 2 postoperative hours

  3. Oxycodone consumption

    Measured: postoperative day 1, 2 and 3

  4. Pain scores at rest

    Measured: postoperative day 1, 2 and 3

  5. Pain scores on movement

    Measured: postoperative day 1, 2 and 3

  6. Forced expiratory volume at 1 sec (FEV1)

    Measured: postoperative day 0, 1, 2 and 3

  7. Forced vital capacity

    Measured: postoperative day 0, 1, 2 and 3

  8. Peak expiratory flow

    Measured: postoperative day 0, 1, 2 and 3

  9. Rate of hemidiaphragmatic paresis

    Measured: postoperative day 0, 2 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02433561
Sponsor's protocol ID
CHUVaudois
Status last verified
Nov 2016
First submitted
20 Oct 2014
Last updated
9 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28403412

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) and Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG) in people with Shoulder Pain and Regional Anesthesia Morbidity, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of hemidiaphragmatic paresis (time frame: 24 postoperative hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02433561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.

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