Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Pain Clinical Trial

— TAPPro  

Official title:

Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625572
• Other study ID #: TAPPro
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: July 28, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Prostatectomy
• Transversus Abdominis Plane Blockade

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in rest in the op-area	Pain in rest in the op-area during the first 3 days	3 days	No
Secondary	Opioid consumption	opioidconsumption during the first 3 days	3 days	No
Secondary	Pain in motion in the op-area	Pain in the op-area in motion during the first three days	3 days	No
Secondary	Pain outside the op-area	Pain outside the op-area during the first three days	3 days	No
Secondary	Contentment with the pain therapy at all	Contentment with the pain therapy at all for the first three days	3 days	No
Secondary	Frequency of postoperative vomiting and nausea	Frequency of postoperative vomiting and nausea during the first three days	3 days	No
Secondary	Incidence of pruritus	Incidence of pruritus during the first three days	3 days	No
Secondary	Tenesmuses of the bladder	Tenesmus of the bladder during the first three days	3 days	No
Secondary	Contentment of the Patient at all	Contentment of the patient at all during the first three days	3 days	No