Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy (TAPPro)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Charite University, Berlin, Germany.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Jurgen Birnbaum, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01625572
First received: June 19, 2012
Last updated: July 24, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Prostatectomy
Transversus Abdominis Plane Blockade
Pain
Procedure: Transversus abdominis plane blockade
Procedure: Morphine-patient-controlled-analgesia-device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Pain in rest in the op-area [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Pain in rest in the op-area during the first 3 days


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    opioidconsumption during the first 3 days

  • Pain in motion in the op-area [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Pain in the op-area in motion during the first three days

  • Pain outside the op-area [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Pain outside the op-area during the first three days

  • Contentment with the pain therapy at all [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Contentment with the pain therapy at all for the first three days

  • Frequency of postoperative vomiting and nausea [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Frequency of postoperative vomiting and nausea during the first three days

  • Incidence of pruritus [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Incidence of pruritus during the first three days

  • Tenesmuses of the bladder [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Tenesmus of the bladder during the first three days

  • Contentment of the Patient at all [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Contentment of the patient at all during the first three days


Estimated Enrollment: 66
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: general anesthesia and epidural catheter (control)

General anaesthesia

  • total intravenous anaesthesia with propofol 5-10 mg / kg / h,
  • remifentanil 0.1 to 0.3 micrograms / kg / min and muscle relaxation with cis-atracurium
  • use of a bispectral index
  • monitoring with a target range of 40-60
  • at the end of the anaesthesia all patients get 0.1 mg / kg morphine intravenously epidural catheter
  • plant of the epidural catheter under sterile conditions at the intervertebral space of the vertebral body 8-10 of the thoracic spine• local anaesthesia with lidocaine 1%
  • puncture with a Tuohy 18 G- needle, Lost of resistance technique
  • after a negative test dose with bupivacaine 0,5% isobar we inject fractional ropivacaine 10 ml 0,2%, after that continuous administration of ropivacaine 0,2% via patient-controlled-analgesia-device with a sweep rate of 6 ml/h, all Patients also receive an intravenous morphine-patient-controlled-analgesia-device
Experimental: general anesthesia and regional anesthesia

General anesthesia

  • anesthesia with propofol 5-10 mg / kg / h, remifentanil 0.1 to 0.3 micrograms / kg / min and muscle relaxation with cis-atracurium
  • Bispektralindex monitoring with a target range of 40-60
  • at the end of the anesthesia all patients get 0.1 mg / kg morphine intravenously Transversus abdominis plane blockade
  • ultrasound visible needles, a special pin detection software
  • under visual control the needle moves into the space between Musculus obliquus internus and M. transversus abdominis
  • Under sonographic control we inject a local anesthetic depot (30 ml of ropivacaine 0.375%)
  • puncture is performed under constant protective nerve stimulation with a current of 1 mA, pulse duration 0.1 ms, frequency 2 Hz All Patients receive an i.v. Morphine-patient-controlled-analgesia-device
Procedure: Transversus abdominis plane blockade
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.
Experimental: general anaesthesia and intravenous pain therapy

General anaesthesia

  • total intravenous anesthesia with propofol 5-10 mg / kg / h, remifentanil 0.1 to 0.3 micrograms / kg / min and muscle relaxation with cis-atracurium
  • we use a of BIS monitoring with a target range of 40-60
  • at the end of the aneasthesia all patients get 0.1 mg / kg morphine intravenously intravenous pain therapy with
  • Morphine-patient-controlled-analgesia-device
Procedure: Morphine-patient-controlled-analgesia-device
Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625572

Contacts
Contact: Jürgen Birnbaum, MD +49 30 450 531052 juergen.birnbaum@charite.de
Contact: Ulrike Haase, MD +49 30 450 531052 ulrike.haase@charite.de

Locations
Germany
Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Sub-Investigator: Frank Nöther, MD         
Sub-Investigator: Ulrike Haase, MD         
Principal Investigator: Jürgen Birnbaum, PD, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Jürgen Birnbaum, MD Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Jurgen Birnbaum, PD Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01625572     History of Changes
Other Study ID Numbers: TAPPro
Study First Received: June 19, 2012
Last Updated: July 24, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
general anaesthesia
epidural catheter
intravenous pain therapy

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014