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

July 28, 2016 updated by: Jurgen Birnbaum, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in rest in the op-area
Time Frame: 3 days
Pain in rest in the op-area during the first 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 3 days
opioidconsumption during the first 3 days
3 days
Pain in motion in the op-area
Time Frame: 3 days
Pain in the op-area in motion during the first three days
3 days
Pain outside the op-area
Time Frame: 3 days
Pain outside the op-area during the first three days
3 days
Contentment with the pain therapy at all
Time Frame: 3 days
Contentment with the pain therapy at all for the first three days
3 days
Frequency of postoperative vomiting and nausea
Time Frame: 3 days
Frequency of postoperative vomiting and nausea during the first three days
3 days
Incidence of pruritus
Time Frame: 3 days
Incidence of pruritus during the first three days
3 days
Tenesmuses of the bladder
Time Frame: 3 days
Tenesmus of the bladder during the first three days
3 days
Contentment of the Patient at all
Time Frame: 3 days
Contentment of the patient at all during the first three days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Jürgen Birnbaum, MD, Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPPro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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