Prostatectomy, Transversus Abdominis Plane Blockade, Pain
Conditions
Keywords
general anaesthesia, epidural catheter, intravenous pain therapy
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.
Interventions
PROCEDURETransversus 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.
PROCEDUREMorphine-patient-controlled-analgesia-device
Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain in rest in the op-area | 3 days | Pain in rest in the op-area during the first 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain in motion in the op-area | 3 days | Pain in the op-area in motion during the first three days |
| Pain outside the op-area | 3 days | Pain outside the op-area during the first three days |
| Contentment with the pain therapy at all | 3 days | Contentment with the pain therapy at all for the first three days |
| Opioid consumption | 3 days | opioidconsumption during the first 3 days |
| Incidence of pruritus | 3 days | Incidence of pruritus during 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 |
Countries
Germany
Outcome results
None listed