Trial document




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  DRKS00007121

Trial Description

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Title

Dosage finding for spinal anaesthesia using chloroprocaine 1% in patients undergoing perianal outpatient surgery.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Benign diseases of the rectum, e.g. hemorrhoids, are frequent amongst the adult population. Roughly 10% of these patients require surgical treatment, more and more in an ambulatory setting. Therefore safe and efficient anesthesia is essential.The saddle-block, a spinal anaesthesia using very small amounts of hyperbaric local anaesthetics, seems to be superior compared to other anaesthesia methods. Using short-acting local anaesthaetics, the saddle-block is also suitable for procedures in an ambulatory setting.
This trial is conducted to identify the "optimal" dosage of Chloroprocain 1% for this indication.
Every patient (male/female) aged 18 to 80 undergoing perianal surgery is able to take part in the trial. Exclusion criteria are contraindication against spinala nesthesia and allergies against local anesthetics or drugs used for postoperative pain therapy.

The participants will be randomized 1:1:1 and receive 10mg, 20mg, or 30mg Chloroprocain 1% for spinal anesthesia.

The expansion of the motor as well as the sensory block will be measured. Time will be counted until patients’ full ability to move, first incidence of pain, spontaneous micturition, postoperative need of analgestics and capability for home-discharge.

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Brief Summary in Scientific Language

Benign diseases of the rectum are frequent amongst the adult population. Roughly 10% of these patients require surgical treatment, more and more in an ambulatory setting. Therefore safe and efficient anesthesia is essential. Previous trials have shown that spinal anesthesia with small amounts of hyperbaric local anesthetics for proctologic surgery seems to be superior compared to other anaesthesia methods in terms of quality of surgical conditions, patients overall satisfaction and postoeprative analgetics requirements. Using short-acting local anaesthaetics, the saddle-block is also suitable for procedures in an ambulatory setting.
Since 2014 the very short acting local anesthetic Chloroprocain 1% has been introduced into the German market. By now there is no evidence based data about dosing chloroprocaine 1% for spinal anesthesia in ambulatory perianal surgery.
The aim of this trial is to identify the "optimal" dosage of Chloroprocain 1% - 10mg, 20mg or 30mg - for this indication in terms of an adequate sensory block, less postoperative pain and adverse side effects (urinary retention) and a minimal duration stay at the day-surgery centre.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007121
  •   2014/10/30
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  •   yes
  •   Approved
  •   2014-571N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   K62 -  Other diseases of anus and rectum
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Interventions/Observational Groups

  •   Spinal anesthesia using 10mg chloroprocaine 1%. Patients Patients have to stay in an upright sitting position for 10min. Expansion of sensory and motor block are measured. Time spans until unassisted ambulation, spontaneous micturition, first occurence of pain andreaddiness for home-discharge are documented.
  •   Spinal anesthesia using 20mg chloroprocaine 1%. Patients Patients have to stay in an upright sitting position for 10min. Expansion of sensory and motor block are measured. Time spans until unassisted ambulation, spontaneous micturition, first occurence of pain andreaddiness for home-discharge are documented.
  •   Spinal anesthesia using 30mg chloroprocaine 1%. Patients Patients have to stay in an upright sitting position for 10min. Expansion of sensory and motor block are measured. Time spans until unassisted ambulation, spontaneous micturition, first occurence of pain andreaddiness for home-discharge are documented.
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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
  •   N/A
  •   No
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Primary Outcome

Duration of stay in the day-surgery centre (from induction of anesthesia to readiness for home discharge in minutes)

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Secondary Outcome

- Expansion of sensory and motor block (modified bromage score, insensitive dermatomes (pinprick) counted upwards from S5)
- time from induction of anesthesia to unassisted ambulation in minutes
- time from induction of anesthesia first spontaneous micturition in minutes
- time from induction of anesthesia to first occurence of pain in minutes
- postoperative demand of analgesics
- incidence of adverse side effects

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/13
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diseases of anus or rectum, that make an operative intervention in an ambulatory setting necessary.

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Exclusion Criteria

Contraindications against spinal anesthesia. Allergies against local anesthetics or against the postoperative used analgetics.

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin der Universitätsmedizin Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin MannheimKlinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Priv.-Doz. Dr. med.  Marc  Schmittner 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin der Universitätsmedizin Mannheim
    • Mr.  Dr. med  Volker  Gebhardt 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Operative Intensivmedizin der Universitätsmedizin Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/23
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Trial Publications, Results and other Documents

  •   Gebhardt V, Mueller-Hansen L, Schwarz A, Bussen D, Weiss C, Schmittner MD. Chloroprocaine 10 mg/ml for low-dose spinal anaesthesia in perianal surgery – a randomised dose finding study. Acta Anaesthesiologica Scandinavica 2017
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* This entry means the parameter is not applicable or has not been set.