Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
- Conditions
- ProstatectomyTransversus Abdominis Plane BlockadePain
- Interventions
- Procedure: Transversus abdominis plane blockadeProcedure: Morphine-patient-controlled-analgesia-device
- Registration Number
- NCT01625572
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
- patients at the age of 18 and above, who need an open prostatectomy
- written consent exists
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description general anesthesia and regional anesthesia Transversus abdominis plane blockade 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 general anaesthesia and intravenous pain therapy Morphine-patient-controlled-analgesia-device 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
- Primary Outcome Measures
Name Time Method Pain in rest in the op-area 3 days Pain in rest in the op-area during the first 3 days
- Secondary Outcome Measures
Name Time Method Contentment with the pain therapy at all 3 days Contentment with the pain therapy at all for the first three days
Tenesmuses of the bladder 3 days Tenesmus of the bladder during the first three days
Contentment of the Patient at all 3 days Contentment of the patient at all during the first three days
Frequency of postoperative vomiting and nausea 3 days Frequency of postoperative vomiting and nausea during the first three days
Incidence of pruritus 3 days Incidence of pruritus during the first three days
Pain outside the op-area 3 days Pain outside the op-area during the first three days
Opioid consumption 3 days opioidconsumption during the first 3 days
Pain in motion in the op-area 3 days Pain in the op-area in motion during the first three days
Trial Locations
- Locations (1)
Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin
🇩🇪Berlin, Germany