Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

NCT ID: NCT01625572

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Transversus abdominis plane blockade

Intervention Type: 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 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

Group Type: EXPERIMENTAL

Morphine-patient-controlled-analgesia-device

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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
• accommodation in an institute due to an official or judicial order

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Birnbaum

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jürgen Birnbaum, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

TAPPro

Identifier Type: -

Identifier Source: org_study_id