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Completed

NCT Number: NCT01625572

Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

The purpose of this study is to compare the quality of a transversus abdominis plane blockade with an intravenous pain therapy with opioids. Due to the relatively low side effect profile and comparably few contraindications, this method offers a good option, to be a standard procedure or better alternative in the treatment of pain in surgery of the prostate.

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Key information

Conditions

Prostatectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Transversus Abdominis Plane Blockade

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients at the age of 18 and above, who need an open prostatectomy
  • written consent exists

Exclusion criteria

  • American Society of Anaesthesiologists (ASA) classification > III
  • Allergy to local anaesthesia
  • Contraindications to one of the applied methods
  • previous surgery on the abdominal wall
  • chronic pain patients
  • Myasthenia gravis
  • alcohol dependence
  • increased intraocular pressure
  • lacking willingness to save and hand out data within the study
  • Participation in another trial according to the German Drug Law
  • accommodation in an institute due to an official or judicial order

Treatment and study plan

Transversus abdominis plane blockade

Procedure

Bilateral one time injection of local anaesthetic in the space between the transversus abdominis muscle and obliquus internus muscle preoperatively. Follow up for three days.

Morphine-patient-controlled-analgesia-device

Procedure

Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.

Primary outcomes

  1. Pain in rest in the op-area

    Time frame: 3 days

    Pain in rest in the op-area during the first 3 days

Secondary outcomes

  1. Opioid consumption

    Time frame: 3 days

    opioidconsumption during the first 3 days

  2. Pain in motion in the op-area

    Time frame: 3 days

    Pain in the op-area in motion during the first three days

  3. Pain outside the op-area

    Time frame: 3 days

    Pain outside the op-area during the first three days

  4. Contentment with the pain therapy at all

    Time frame: 3 days

    Contentment with the pain therapy at all for the first three days

  5. Frequency of postoperative vomiting and nausea

    Time frame: 3 days

    Frequency of postoperative vomiting and nausea during the first three days

  6. Incidence of pruritus

    Time frame: 3 days

    Incidence of pruritus during the first three days

  7. Tenesmuses of the bladder

    Time frame: 3 days

    Tenesmus of the bladder during the first three days

  8. Contentment of the Patient at all

    Time frame: 3 days

    Contentment of the patient at all during the first three days

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: TAPPro

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2012
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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