Pain, PostoperativePhase 2TAP RCTNCT03149783
Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
A Phase 2 study testing Ropivacaine HCL and sodium chloride in people with Pain, Postoperative and Delirium, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pain, Postoperative, Delirium, Anesthesia, Local
- What is being tested?
- Ropivacaine HCL and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 31 Oct 2021
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=50 years.
- Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.
Who cannot join
- Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
- Patients with an epidural or spinal catheter block.
- Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
- Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded.
- History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
- Patients with a documented allergy to ropivacaine or other sodium channel blockers.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Denver Veterans Affairs Medical Center
Denver, Colorado, 80221
Thomas Robinson, MD, 303-399-8020 ext. 2952, thomas.robinson@ucdenver.edu
Douglas Overbey, MD, 573-225-7728, douglas.overbey@ucdenver.edu
About this study
Official title: A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.
This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
- Conditions
- Pain, Postoperative, Delirium, Anesthesia, Local
- Being tested
- Ropivacaine HCL, sodium chloride
- Medical subject headings
- Pain, Postoperative, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine HCLDrug
Ropivacaine injected after placement of catheters, then infused during the operation
sodium chlorideDrug
Also called saline
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine. Receives: Drug: Ropivacaine HCL |
| Placebo | Placebo comparator | Participants will have bilateral TAP catheters placed along with continuous infusion of placebo. Receives: Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain scores from the visual analog scale
Measured: Days 0-7 following the operation
Secondary outcomes (2)
Amount of anesthetic
MAC of inhalational agent, or total amount of IV anesthetic used during the operation
Measured: During the operation
Amount of narcotic administered postoperatively
Amount of morphine equivalents per day measured after the operation
Measured: Days 0-7 postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Feb 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Double Blind Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Robinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149783
- Sponsor's protocol ID
- 16-1078
- Acronym
- TAP RCT
- Status last verified
- May 2021
- First submitted
- 10 Mar 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Determine if Pre- and Post- Operative Regional Pain Control (Transversus Abdominis Plane Block) With Ropivacaine Versus Placebo Leads to Lower Anesthetic and Narcotic Dosing, and Alters Pain Scores
- ClinicalTrials.gov ID
- NCT03149783
- Acronym / sponsor ID
- TAP RCT / 16-1078
- Conditions
- Pain, Postoperative, Delirium, Anesthesia, Local
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 11 May 2017 (actual)
- 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.
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.
This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Double Blind Trial
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine HCLParticipants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine. |
| Placebo | Placebo comparator | Drug: sodium chlorideParticipants will have bilateral TAP catheters placed along with continuous infusion of placebo. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=50 years.
- Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.
Key exclusion criteria (6 listed)
- Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
- Patients with an epidural or spinal catheter block.
- Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
- Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded.
- History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
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 |
|---|---|---|
| Ropivacaine HCLRopivacaine injected after placement of catheters, then infused during the operation | Drug | Ropivacaine |
| sodium chlorideAlso: salinePlacebo | Drug | Placebo |
Primary outcome
Pain Scores
Time frame: Days 0-7 following the operation
Pain scores from the visual analog scale
2 secondary outcomes
Amount of anesthetic
Time frame: During the operation
Amount of narcotic administered postoperatively
Time frame: Days 0-7 postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No. No sharing
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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.
Thomas Robinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine HCL and sodium chloride in people with Pain, Postoperative and Delirium, run by University of Colorado, Denver 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 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas Overbey, MD (573-225-7728, douglas.overbey@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Days 0-7 following the operation). 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 27 May 2021.