Trial document




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  DRKS00011234

Trial Description

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Title

Pain and quality of life after orthopaedic surgery: Are our strategies sufficient to allow smooth transition from inpatient to outpatient care


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Trial Acronym

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URL of the Trial

http://none

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Hospitals are increasingly under pressure to discharge patients early after surgery. As a consequence pain remains often insufficiently treated [1].
Evidence suggests especially the early phase after hospital discharge is critical as patients rarely receive sufficient pain management [2–4].
Monitoring pain after discharge is challenging. For instance, for our institution there is no pathway to systematically follow up patients' pain experience. Therefore gaining insight into patients' post discharge experience is important to improve services.
Avoiding uncessary pain and suffering in the early post-operative phase is important as it might not only negatively impact surgical outrcome but also lead to chronification of pain [2,5]. Chronic post surgical pain (CPSP) considerably reduces patients' quality of life (QoL) and ability to work [1]. Better pain management has been suggested not only to improve QoL but also help rehabilitation and subsequently facilitate a quicker return to work [6,7].
Pain is a complex phenomenon, requiring individualized strategies [8]. Therefore there is a plethora of options for the anaesthetis to choose from. Especially in orthopaedic surgery systemic analgesia is often complemented by regional anaesthesia [9].
There are many possible advantages of regional anaesthesia compared to systemic analgesics in the early post-operative phase. However, whether these techniques also impact on pain after discharge remains to be determined.
Aim of this study is hence to investigate a) pain intensity, analgesic consumption and QoL up to 4 weeks after keyhole orthopaedic surgery and b) to explore, whether employed analgesic strategies (regional vs systemic) make a difference to the pain experienced in the first 4 weeks after surgery.


References:
1. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. European journal of pain (London, England) 2006;10:287–333.
2. Gerbershagen HJ. Chronifizierung postoperativer Schmerzen. Physiologie, Risikofaktoren und Prävention. Schmerz (Berlin, Germany) 2013;27:81-93; quiz 94-5.
3. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesthesia and analgesia 2003;97:534-40, table of contents.
4. Richman JM, Liu SS, Courpas G, Wong R, Rowlingson AJ, McGready J, et al. Does continuous peripheral nerve block provide superior pain control to opioids? A meta-analysis. Anesthesia and analgesia 2006;102:248–257.
5. Esther Pogatzki-Zahn. Chronische Schmerzen nach Operationen: Prävention und Therapie. Anästhesiologische Intensivtherapie Notfallmedizin Schmerztherapie 2010;45:496–503.
6. Barreveld A, Witte J, Chahal H, Durieux ME, Strichartz G. Preventive analgesia by local anesthetics: the reduction of postoperative pain by peripheral nerve blocks and intravenous drugs. Anesthesia and analgesia 2013;116:1141–1161.
7. Dworkin RH, Jensen MP, Gould E, Jones BA, Xiang Q, Galer BS, et al. Treatment satisfaction in osteoarthritis and chronic low back pain: the role of pain, physical and emotional functioning, sleep, and adverse events. The journal of pain : official journal of the American Pain Society 2011;12:416–424.
8. Bantel C, Laycock H, Ward S, Halmshaw C, Nagy I. Pain in Intensive Care: A Personalised Healthcare Approach. Journal of the Intensive Care Society 2013;14:312–318.
9. Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesthesia and analgesia 2007;105:789–808.
10. Schwenkglenks M. Correlates of satisfaction with pain treatment in the acute postoperative period: Results from the international PAIN OUT registry.
11. Usichenko TI, Röttenbacher I, Kohlmann T, Jülich A, Lange J, Mustea A, et al. Implementation of the quality management system improves postoperative pain treatment: a prospective pre-/post-interventional questionnaire study. British journal of anaesthesia 2013;110:87–95.
12. Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EKB, et al. Assessment of pain. British journal of anaesthesia 2008;101:17–24.

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Organizational Data

  •   DRKS00011234
  •   2016/10/28
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  •   yes
  •   Approved
  •   105/2016, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   Arthroscopic surgery to ankle, knee, or shoulder
  •   M14 -  Arthropathies in other diseases classified elsewhere
  •   M22 -  Disorders of patella
  •   M23 -  Internal derangement of knee
  •   M24 -  Other specific joint derangements
  •   M25 -  Other joint disorders, not elsewhere classified
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Interventions/Observational Groups

  •   Patients who undergo arthroscopic surgery to ankle, knee, or shoulder and receive intra-operatively either regional anaesthesia or systemic analgesics only.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Assessment of pain scores unsing a numerial rating scale, consumption of analgesics (review of medical notes and patient interviews) and quality of life employing a questionnaire.
Assessmets are made on the 2nd, 7th and 30th post-operative day.

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Secondary Outcome

Comparison of pain scores unsing a numerial rating scale, consumption of analgesics (review of medical notes and patient interviews) and quality of life employing a questionnaire between patients who received regional anaesthesia and patients who received systemic anagesics only.
Assessmets are made on the 2nd, 7th and 30th post-operative day.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Arthroscopic surgery to ankle, knee, or shoulder; age: >18 years; ASA 1 or 2 patients; fluent in German

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Exclusion Criteria

Age: <18 years; ASA >2 patients; chronic pain patients; reduced ability to communicate (Konfusion, not fluent in German, not able to communicate via the telephone);
revision surgery; treatment in critical care post-operatively; severe intra-operative complications; previous surgery in the surgical region, non-avaiability within the first weeks post surgery; transfer to a rehabilitation clinic; pregnancy


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Addresses

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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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    • Universitätsklinik für Anästhesiologie, Intensiv-, Notfallmedizin und Schmerztherapie
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Anästhesiologie, Intensiv-, Notfallmedizin und SchmerztherapieKlinikum Oldenburg AöR
    • Mr.  Dr  Carsten  Bantel 
    • Rahel Strauss Strasse 10
    • 26133  Oldenburg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2017/11/22
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Trial Publications, Results and other Documents

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