ProstatectomyTAPProNCT01625572
Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
A study testing Transversus abdominis plane blockade in people with Prostatectomy and Transversus Abdominis Plane Blockade, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy, Transversus Abdominis Plane Blockade, Pain
- What is being tested?
- Transversus abdominis plane blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients at the age of 18 and above, who need an open prostatectomy
- written consent exists
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine Campus Charitè Mitte, Charite Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
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
- Being tested
- Transversus abdominis plane blockade, Morphine-patient-controlled-analgesia-device
- Keywords
- general anaesthesia, epidural catheter, intravenous pain therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockadeProcedure or surgery
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.
Morphine-patient-controlled-analgesia-deviceProcedure or surgery
Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia and epidural catheter (control) | No intervention | 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 | 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 Receives: Procedure: Transversus abdominis plane blockade |
| general anaesthesia and intravenous pain therapy | Experimental | 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 Receives: Procedure: Morphine-patient-controlled-analgesia-device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in rest in the op-area
Pain in rest in the op-area during the first 3 days
Measured: 3 days
Secondary outcomes (8)
Opioid consumption
opioidconsumption during the first 3 days
Measured: 3 days
Pain in motion in the op-area
Pain in the op-area in motion during the first three days
Measured: 3 days
Pain outside the op-area
Pain outside the op-area during the first three days
Measured: 3 days
Contentment with the pain therapy at all
Contentment with the pain therapy at all for the first three days
Measured: 3 days
Frequency of postoperative vomiting and nausea
Frequency of postoperative vomiting and nausea during the first three days
Measured: 3 days
Incidence of pruritus
Incidence of pruritus during the first three days
Measured: 3 days
Tenesmuses of the bladder
Tenesmus of the bladder during the first three days
Measured: 3 days
Contentment of the Patient at all
Contentment of the patient at all during the first three days
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Birnbaum, Charite University, Berlin, Germany
- Investigators
- Jürgen Birnbaum, MD, Principal investigator, Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625572
- Sponsor's protocol ID
- TAPPro
- Acronym
- TAPPro
- Status last verified
- Jul 2016
- First submitted
- 19 Jun 2012
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy
- ClinicalTrials.gov ID
- NCT01625572
- Acronym / sponsor ID
- TAPPro / TAPPro
- Conditions
- Prostatectomy, Transversus Abdominis Plane Blockade, Pain
- Keywords
- general anaesthesia, epidural catheter, intravenous pain therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia and epidural catheter (control) | No intervention | –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 | Procedure: Transversus abdominis plane blockadeGeneral 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 | Experimental | Procedure: Morphine-patient-controlled-analgesia-deviceGeneral 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients at the age of 18 and above, who need an open prostatectomy
- written consent exists
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane blockadeBilateral one time injection of local anaesthetic in the space between the transversus abdominis muscle and obliquus internus muscle preoperatively. Follow up for three days. | Procedure or surgery | general anesthesia and regional anesthesia |
| Morphine-patient-controlled-analgesia-deviceMorphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible. | Procedure or surgery | general anaesthesia and intravenous pain therapy |
Primary outcome
Pain in rest in the op-area
Time frame: 3 days
Pain in rest in the op-area during the first 3 days
8 secondary outcomes
Opioid consumption
Time frame: 3 days
Pain in motion in the op-area
Time frame: 3 days
Pain outside the op-area
Time frame: 3 days
Contentment with the pain therapy at all
Time frame: 3 days
Frequency of postoperative vomiting and nausea
Time frame: 3 days
Incidence of pruritus
Time frame: 3 days
Tenesmuses of the bladder
Time frame: 3 days
Contentment of the Patient at all
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Birnbaum, MD principal investigator
Charite, Department of Anesthesiology and Intensive Care, Campus Mitte, Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane blockade in people with Prostatectomy and Transversus Abdominis Plane Blockade, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in rest in the op-area (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.