Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

NCT01625572 | Completed

• 1 other identifier: TAPPro
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Transversus Abdominis Plane Blockade; Pain

Keywords

general anaesthesia; epidural catheter; intravenous pain therapy

Outcome Measures

Primary Outcomes (1)

• Pain in rest in the op-area

  Pain in rest in the op-area during the first 3 days

  3 days

Secondary Outcomes (8)

• Opioid consumption

  3 days

• Pain in motion in the op-area

  3 days

• Pain outside the op-area

  3 days

• Contentment with the pain therapy at all

  3 days

• Frequency of postoperative vomiting and nausea

  3 days

Study Arms (3)

general anesthesia and epidural catheter (control)

NO INTERVENTION

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

general anesthesia and regional anesthesia

EXPERIMENTAL

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

general anaesthesia and intravenous pain therapy

EXPERIMENTAL

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

Interventions

Transversus abdominis plane blockade PROCEDURE

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.

general anesthesia and regional anesthesia

Morphine-patient-controlled-analgesia-device PROCEDURE

Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.

general anaesthesia and intravenous pain therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients at the age of 18 and above, who need an open prostatectomy
• written consent exists

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jürgen Birnbaum, MD

  Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

DE (1)