Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy (TAPPro)

Charité University Medicine Berlin

Status: Completed

Conditions: Prostatectomy; Transversus Abdominis Plane Blockade; Pain

Treatments: Procedure: Transversus abdominis plane blockade; Procedure: Morphine-patient-controlled-analgesia-device

Study type: Interventional

Funder types: Other

Identifiers

NCT01625572

TAPPro

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

general anesthesia and epidural catheter (control)

No Intervention group

Description:

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 group

Description:

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

Treatment:

Procedure: Transversus abdominis plane blockade

general anaesthesia and intravenous pain therapy

Experimental group

Description:

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

Treatment:

Procedure: Morphine-patient-controlled-analgesia-device