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Clinical Trials/NCT01625572
NCT01625572
Completed
Not Applicable

Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Charite University, Berlin, Germany1 site in 1 country66 target enrollmentJuly 2012
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ConditionsProstatectomyTransversus Abdominis Plane BlockadePain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatectomy
Sponsor
Charite University, Berlin, Germany
Enrollment
66
Locations
1
Primary Endpoint
Pain in rest in the op-area
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jurgen Birnbaum

PD Dr. med.

Charite University, Berlin, Germany

Eligibility 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

Outcomes

Primary Outcomes

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

  • Contentment with the pain therapy at all(3 days)
  • Tenesmuses of the bladder(3 days)
  • Contentment of the Patient at all(3 days)
  • Frequency of postoperative vomiting and nausea(3 days)
  • Pain outside the op-area(3 days)
  • Opioid consumption(3 days)
  • Pain in motion in the op-area(3 days)
  • Incidence of pruritus(3 days)

Study Sites (1)

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