Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Not Applicable

Completed

• Conditions: Prostatectomy; Transversus Abdominis Plane Blockade; Pain

• Registration Number: NCT01625572
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Study Start: 2012-07
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain in rest in the op-area	3 days	Pain in rest in the op-area during the first 3 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany