Trial document





This trial has been registered retrospectively.
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  DRKS00020938

Trial Description

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Title

Influence of different catheter designs for distal sciatic nerve blockade on postoperative pain intensity- a randomised controlled trial

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Trial Acronym

CathPopSci

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients who are operated on their lower leg or foot and receive a distal sciatic catheter as a regional anaesthetic for postoperative pain therapy will be examined here. For this purpose, a thin catheter is placed on the sciatic nerve in the hollow of your knee before the actual operation. This is done by an anaesthetist using ultrasound control under local anaesthetic at the injection site. In this study, a newly developed curl catheter end will be compared with the conventional straight catheter ends used so far. It will be examined whether there are differences between them with regard to postoperative pain therapy including positional stability.

To conduct the study, patients will receive one of the two catheters described above. The application is carried out by an anaesthetist under ultrasound control immediately before the operation. This type of sciatic blockade is performed several times a day in routine operation by medical staff of the anaesthesia department or under the guidance of experienced specialists or senior physicians. Both types of catheter are commonly used and are considered to be equivalent. After the operation, patients remain in the recovery room to monitor their vital parameters. This is where their current pain level is first recorded. Further checks by our acute pain service and the nursing staff are carried out at regular intervals.
For possible pain phases, they are given additional strong painkillers (Oxycodon) if required. These can be obtained from the nursing staff at any time. This ensures pain treatment even in case of a malposition of the pain catheter.
The position of the pain catheter is checked and documented on the 1st-3rd postoperative day by injecting sterile saline solution under ultrasound control.

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Brief Summary in Scientific Language

Peripheral regional anaesthesia is constantly developing at a rapid pace. A novel catheter design for regional anaesthesia has been available for some time. A special feature here is a preformed C-shaped end with lateral openings. It has not yet been clarified whether this has any demonstrable advantages for the patient.
Objectives: The curl catheter is compared with the conventional design for popliteal sciatic blockade. The primary endpoint of this study is pain intensity on the day of surgery and the following three postoperative days. Secondary endpoints investigate dislocation rate in situ, externally visible catheter movement, opioid consumption and patient satisfaction, as well as local anesthetic consumption and bolus delivery.
Methods: After a successful ethics vote (EK150042016), 140 patients undergoing elective surgery on the distal lower leg or foot received a distal sciatic catheter. After randomization, 70 SLS and 70 SLC catheters were successfully placed preoperatively under ultrasonographic control. The placement was performed at the level of the bifurcation of the sciatic nerve in short axis technique (SAX) with in-plane visibility (IP) of the needle. The subjective pain intensity was determined postoperatively using visual analogue scale (VAS) at fixed times for three days (PACU, 2 h postoperatively, two measuring points each at POD 1, 2 and 3). In addition, daily sonographic position checks of the catheters as well as the recording of the oxycodone consumption as rescue medication, the external visible movement of the catheter, the ropivacaine consumption and possible bolus expenditure took place. After removal of the catheters, the patients were asked about their satisfaction with the pain therapy procedure.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

study protocol

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Organizational Data

  •   DRKS00020938
  •   2020/04/08
  •   [---]*
  •   yes
  •   Approved
  •   EK150042016, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   findings requiring surgery on the distal lower leg / ankle or foot
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Interventions/Observational Groups

  •   curl-catheter placement
  •   conventional straight catheter placement
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Characteristics

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

postoperative pain intensity on the day of surgery and on three subsequent days by means of NRS recording twice a day

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Secondary Outcome

In addition, the position of the pain catheters is recorded by means of sonographic control immediately after the operation and once a day on the first three postoperative days. Further parameters such as additional consumption of painkillers, amount of local anaesthetics administered, assessment of the puncture site and potential side effects are documented once a day. Finally, the time of catheter removal and patient satisfaction with the procedure is recorded with an NRS of 0 (completely dissatisfied) to 10 (very satisfied).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/14
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- patients' consent form
- indication for the placement of a distal ischiadicus blockage in the context of a surgical Intervention
- age between 18 and 75 years

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Exclusion Criteria

- chronic pain
- refusal of regional anaesthesia
- intolerance or allergy to ropivacaine or oxycodone
- neuromuscular diseases
- BMI > 35
- Polyneuropathy or ipsilateral neuropathy
- pre-existing opioid medication

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Addresses

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    • Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Carl Gustav Carus Dresden
    • Ms.  Rosa  Nickl 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Carl Gustav Carus Dresden
    • Mr.  PD Dr. med.  Torsten  Richter 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Carl Gustav Carus Dresden
    • Mr.  Dr.med.  Oliver  Vicent 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Carl Gustav Carus Dresden
    • Ms.  Rosa  Nickl 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Carl Gustav Carus Dresden
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/06
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.