PainNCT01679106
The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation
A study testing TAP catheter with Ropivicaine in people with Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- TAP catheter with Ropivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2014
- 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
- The patient is >18 years of age
- The patient has provided written informed consent and understands the explanation of the protocol.
- The patient is scheduled to have a unilateral renal transplant with a flank incision
Who cannot join
- Patients aged <18.
- Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.
- Patients who are unable to understand the verbal analog pain scale.
- Patients who decline participation.
- Patients with a midline abdominal incision.
- Combined transplants, ie. Kidney-pancreas
Trial locations and contacts
1 site in 1 country.
About this study
Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.
Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA
Read more
The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.
The investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.
- Conditions
- Pain
- Being tested
- TAP catheter with Ropivicaine, Fentanyl IV PCA and placebo TAP catheter
- Keywords
- renal transplant, flank incision
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP catheter with RopivicaineOther
Patients will receive TAP catheter with continuous infusion of Ropivicaine.
Fentanyl IV PCA and placebo TAP catheterOther
Patients will receive placebo TAP catheter with Fentanyl IV PCA.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl IV PCA and placebo TAP catheter | Placebo comparator | Patients will receive Fentanyl IV PCA and placebo TAP catheter. Receives: Other: Fentanyl IV PCA and placebo TAP catheter |
| TAP catheter with continuous infusion of Ropivicaine | Active comparator | Patients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery. Receives: Other: TAP catheter with Ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of continuous TAP analgesia and pain scores
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: day 1
Effect of TAP analgesia and opioid requirements
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 1
Effect of continuous TAP analgesia on pain scores
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 2
effect of continuous TAP analgesia on pain scores
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 3
Effect of continuous TAP analgesia on pain scores
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: 30 days
Effect of TAP analgesia on opioid requirements
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 2
Effect of TAP analgesia on opioid requirements
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 3
Effect of TAP analgesia on opioid requirements
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Study closed because of low enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehab Farag, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679106
- Sponsor's protocol ID
- 12-559
- Status last verified
- May 2016
- First submitted
- 31 Aug 2012
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Transversus Abdominis Plane (TAP) Catheters on Postoperative Pain After Renal Transplantation
- ClinicalTrials.gov ID
- NCT01679106
- Acronym / sponsor ID
- 12-559
- Conditions
- Pain
- Keywords
- renal transplant, flank incision
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed because of low enrolment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Sep 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.
Up to 174 patients undergoing renal transplantation will be randomized to one of two groups. Randomization will be based on computer-generated codes using random block sizes ranging from 4 to 8.
Group 1: TAP catheter with continuous infusion of Ropivicaine Group 2: Fentanyl IV PCA
The TAP catheter will be removed 48 hours postoperatively. Following removal, the pain scores will be assessed at 60 and 72 hours postoperatively to determine any prolonged analgesic benefit. In addition, the presence of any pain at the incision site will be noted at the 1 month surgical follow-up to determine any evidence of chronic pain.
The investigators hypothesis is that unilateral kidney transplant patients with a continuous TAP catheter will have decreased pain scores and opioid usage compared to those receiving standard analgesic therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl IV PCA and placebo TAP catheter | Placebo comparator | Other: Fentanyl IV PCA and placebo TAP catheterPatients will receive Fentanyl IV PCA and placebo TAP catheter. |
| TAP catheter with continuous infusion of Ropivicaine | Active comparator | Other: TAP catheter with RopivicainePatients will receive TAP catheter with continuous infusion of Ropivicaine for up to 48 hours after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is >18 years of age
- The patient has provided written informed consent and understands the explanation of the protocol.
- The patient is scheduled to have a unilateral renal transplant with a flank incision
Key exclusion criteria (6 listed)
- Patients aged <18.
- Patients with a known allergy to amide local anesthetics or para-aminobenzoic acid.
- Patients who are unable to understand the verbal analog pain scale.
- Patients who decline participation.
- Patients with a midline abdominal incision.
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 catheter with RopivicainePatients will receive TAP catheter with continuous infusion of Ropivicaine. | Other | TAP catheter with continuous infusion of Ropivicaine |
| Fentanyl IV PCA and placebo TAP catheterPatients will receive placebo TAP catheter with Fentanyl IV PCA. | Other | Fentanyl IV PCA and placebo TAP catheter |
Primary outcome
Effect of continuous TAP analgesia and pain scores
Time frame: day 1
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of TAP analgesia and opioid requirements
Time frame: Day 1
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of continuous TAP analgesia on pain scores
Time frame: Day 2
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
effect of continuous TAP analgesia on pain scores
Time frame: Day 3
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of continuous TAP analgesia on pain scores
Time frame: 30 days
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of TAP analgesia on opioid requirements
Time frame: Day 2
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of TAP analgesia on opioid requirements
Time frame: Day 3
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Effect of TAP analgesia on opioid requirements
Time frame: Day 30
The primary objective is to evaluate the influence of a continuous TAP analgesia on postoperative analgesia (as defined by pain scores and opioid requirements) in patients undergoing renal transplantation, compared to standard analgesic management (IV PCA).
Results and safety
The study was stopped early (reason given: Study closed because of low enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 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.
Ehab Farag, M.D. principal investigator
The Cleveland 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 TAP catheter with Ropivicaine in people with Pain, run by The Cleveland 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 May 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 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 was stopped early (reason given: Study closed because of low enrolment). Results are not available in the source record.
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?
Effect of continuous TAP analgesia and pain scores (time frame: day 1). The study lists 8 primary outcomes in all. 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 23 May 2016.