NephrectomyNCT01054469
Transversus Abdominus Plane Block
A study testing Placement of block with ropivacaine in people with Nephrectomy, run by Mayo Clinic at 1 site in United States.
Trial summary
Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Placement of block with ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are ≥ 18 and ≤ 80 years of age.
- Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.
Who cannot join
- Patients scheduled to undergo an open procedure for nephrectomy
- Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
- Bilateral nephrectomy
- Pregnant or lactating patients
- Patients unable or unwilling to provide informed consent
- Patients unable to comprehend the use of a visual analog scale
Show all 11Show fewer
- Patients desiring preemptive antiemetics
- Opioid tolerance
- Allergy to amide local anesthetics or any of the study drugs (morphine).
- Contraindication to regional nerve block (bleeding disorder, infection at site of block)
- Patients with history of dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.
- Conditions
- Nephrectomy
- Being tested
- TAP block placement with placebo, Placement of block with ropivacaine
- Keywords
- nephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block placement with placeboProcedure or surgery
20 ml of normal saline (placebo)
Placement of block with ropivacaineProcedure or surgery
20 ml of 0.5% ropivacaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| TAP block with placebo | Placebo comparator | Not described Receives: Procedure: TAP block placement with placebo |
| TAP block with ropivacaine | Active comparator | Not described Receives: Procedure: Placement of block with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.
Measured: 24 hours postoperatively
Secondary outcomes (1)
TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Stephen Aniskevich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054469
- Sponsor's protocol ID
- 08-003563
- Status last verified
- Jun 2012
- First submitted
- 20 Jan 2010
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
- ClinicalTrials.gov ID
- NCT01054469
- Acronym / sponsor ID
- 08-003563
- Conditions
- Nephrectomy
- Keywords
- nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Jan 2010 (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.
Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with placebo | Placebo comparator | Procedure: TAP block placement with placebo |
| TAP block with ropivacaine | Active comparator | Procedure: Placement of block with ropivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are ≥ 18 and ≤ 80 years of age.
- Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.
Key exclusion criteria (11 listed)
- Patients scheduled to undergo an open procedure for nephrectomy
- Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
- Bilateral nephrectomy
- Pregnant or lactating patients
- Patients unable or unwilling to provide informed consent
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 |
|---|---|---|
| TAP block placement with placebo20 ml of normal saline (placebo) | Procedure or surgery | TAP block with placebo |
| Placement of block with ropivacaine20 ml of 0.5% ropivacaine hydrochloride | Procedure or surgery | TAP block with ropivacaine |
Primary outcome
Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.
Time frame: 24 hours postoperatively
1 secondary outcome
TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital
Time frame: 24 hours postoperatively
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 21 Jun 2012.
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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.
Stephen Aniskevich, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of block with ropivacaine in people with Nephrectomy, run by Mayo Clinic at 1 site in United States.
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 21 Jun 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy. (time frame: 24 hours postoperatively). 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 21 Jun 2012.