Trial document





This trial has been registered retrospectively.
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  DRKS00009565

Trial Description

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Title

Anterior suprascapular nerve block vs. interscalene brachial plexus block for shoulder surgery in the outpatient setting: a randomized, controlled, patient and assessor blinded trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The reason of this study is a comparison between two different nerve block procedures using local anesthetics with the aim of postoperative analgesia after outpatient shoulder surgery.
Shoulder surgeries are among the most painful procedures. For this reason, nerve blocks as highly efficient analgesic methods are well established.
The standard of care for regional anesthesia/analgesia after shoulder surgery, so far, has been the injection of local anesthetic areound the nerve plexus at the neck, from where nerves to shoulder, arm, hand and diaphragm originate. This procedure is highly effective, but certain complications and side effects have to be considered. These can impair the patient's mobility for 24 hours after surgery because of a motor block of the hand. Shortness of breath as a result of transient impairment of diaphragmatic function may also lead to hospitalization.
This investigation tests whether the nerve block of a single, more peripheral, nerve innervating the shoulder will lead to comparable analgesia but greater patient satisfaction and less impairment of mobility, when compared to the standard block at the neck. Patients will be asked for written informed consent and afterwards randomized to receive either the new, more peripheral, nerve block or the standard nerve block at the neck.
Both nerve blocks will be performed under sonographic guidance of needle. Quality of pain controll, hand strength, satisfaction with the procedure as well as side effects or complications will be recorded.
Patients scheduled for outpatient shoulder surgery are eligible for this study.

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Brief Summary in Scientific Language

Ultrasound-guided interscalene brachial plexus block is compared to ultrasound-guided anterior suprascapular nerve blocks for outpatients undergoing arthroscopic shoulder surgery regarding analgesia, motor block of the hand and patient satisfaction

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Organizational Data

  •   DRKS00009565
  •   2016/01/04
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-8/13-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Pain after outpatient arthroscopic shoulder surgery
  •   regional anesthesia for postoperative analgesia
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Interventions/Observational Groups

  •   ultrasound-guided interscalene brachial plexus block
  •   ultrasound-guided anterior suprascapular nerve block
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

The primary outcome measures of this study were
1) the quality of pain control (numerical rating scale, NRS, at rest, with 0 = no pain, 10 = worst imaginable pain), and

2) and the intensity of motor block of the hand, assessed using the Modified Medical Research Council Scale for measuring hand muscles strength, cf. Brandsma JW, Schreuders TA: Sensible manual muscle strength testing to evaluate and monitor strength of the intrinsic muscles of the hand: a commentary. J Hand Ther 2001; 14:273-8, grade 1 = no motion / palpable muscle contraction only, grade 2 = reduced motion / no muscle resistance, Grad 3 = full motion / no muscle resistance, Grad 4 = full motion / reduced muscle resistance, Grad 5 = full motion / normal muscle resistance.

Data was assessed prior to the operation as well as 10 min, 30 min, 240 min and 1440 minutes after the operation.

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Secondary Outcome

Secondary outcomes included the proportion of patients with considerable pain (NRS>3), dose of the opioid Piritramid in the post-anaesthesia care unit and number of Ibuprofen tablets taken in the first 24 hours.
Further secondary outcomes were patient satisfaction, whether patients would recommend the regional anaesthesia technique received to friends or family. Patients were asked to rank their satisfaction with pain control and were about how strongly they would recommend the regional anesthesia to friends or family, both on a 5 point Likert scale.
We also recorded complications.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/02/18
  •   341
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All patients scheduled for ambulatory arthroscopic shoulder surgery under general anaesthesia with an American Society of Anesthesiologists (ASA) physical status classification score between 1 and 3 were included consecutively in the trial. Patients had to be over 18 years of age. Written informed consent.

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Exclusion Criteria

Patients were excluded if they were allergic to the local anaesthetic, had coagulation disorders, diabetes mellitus, anatomical anomalies, neuropathies, a body mass index > 35 kg/m2 or were pregnant.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Acqua Klinik Leipzig, Anästhesie
    • Mr.  Dr. med.  Martin  Wiegel 
    • Käthe-Kollwitz-Str. 64
    • 04109  Leipzig
    • Germany
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    •   0341 33733110
    •   [---]*
    •   wiegel at me.com
    •   [---]*
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    • Universitätsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
    • Mr.  PD Dr. med.  Andreas  Reske 
    • Liebigstraße 20
    • 04103  Leipzig
    • Germany
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  • start of 1:1-Block address public-contact
    • Acqua Klinik Leipzig, Anästhesie
    • Mr.  Dr. med.  Martin  Wiegel 
    • Käthe-Kollwitz-Str. 64
    • 04109  Leipzig
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   0341 33733110
    •   [---]*
    •   wiegel at me.com
    •   [---]*
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Sources of Monetary or Material Support

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    • Acqua Klinik Leipzig, Anästhesie
    • Mr.  Dr. med.  Martin  Wiegel 
    • Käthe-Kollwitz-Str. 64
    • 04109  Leipzig
    • Germany
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    •   0341 33733110
    •   [---]*
    •   wiegel at me.com
    •   [---]*
    end of 1:1-Block address contact materialSupport
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/17
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Trial Publications, Results and other Documents

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