Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

Conditions
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Prostatectomy, Transversus Abdominis Plane Blockade, Pain

Intervention / Treatment
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* Procedure: Transversus abdominis plane blockade
* Procedure: Morphine-patient-controlled-analgesia-device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: general anesthesia and epidural catheter (control)<br>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 | |
| Experimental: general anesthesia and regional anesthesia<br>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<br>* 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.<br>|
| Experimental: general anaesthesia and intravenous pain therapy<br>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<br>* Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in rest in the op-area | Pain in rest in the op-area during the first 3 days | 3 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anaesthesia, epidural catheter, intravenous pain therapy