Incisional PainPhase 4NCT00944151
Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia
A Phase 4 study testing TAP Catheter and Infusion of Study Solution in people with Incisional Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
Research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Pain
- What is being tested?
- TAP Catheter and Infusion of Study Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2010
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing ambulatory inguinal and/or abdominal surgery amenable to a Transversus Abdominis Plane nerve block (unilateral or bilateral).
- expected postoperative pain to be at least moderate in severity the day following surgery
- age 18 years or older
- desires a regional anesthetic for postoperative analgesia
- is able to understand the possible perineural infusion-related complications, study protocol, and catheter/pump care
- has a caretaker through the first night after surgery
- has an ASA Physical Status Classification of 1-3
Who cannot join
- any contraindication for a continuous Transversus Abdominis Plane nerve block
- any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- current chronic opioid or tramadol use
- history of alcohol or opioid abuse
- know allergy or other contraindication to the study medication
- pregnancy
Show all 11Show fewer
- known hepatic or renal insufficiency/disease
- peripheral neuropathy of the surgical site
- morbid obesity
- inability to communicate with the investigators and hospital staff
- incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study
Research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. This study will also help determine if patients require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their postoperative pain control.
Read the detailed description
Specific Aim: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in improved postoperative pain control.
Hypothesis 1: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in lower average pain scores during movement the day following surgery.
Specific Aim2: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, opioid use, sleep disturbances, and improved patient satisfaction.
Hypothesis 2: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, oral opioid consumption, sleep disturbances, and improved patient satisfaction the day following surgery.
- Conditions
- Incisional Pain
- Being tested
- TAP Catheter and Infusion of Study Solution
- Keywords
- pain, UCSD, catheter, nerve block, hernia, post-surgery pain, abdominal pain, pelvic pain, Transversus abdominal plane, Hernia Repair, Transversus Abdominal Plane Block
- Medical subject headings
- Pain, Hernia, Abdominal Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Catheter and Infusion of Study SolutionProcedure or surgery
Subject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in.
| Study group | Role | What they receive |
|---|---|---|
| Single injection with Saline infused TAP catheter | Placebo comparator | Prior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given normal saline in infusion pump, attached to catheter. Receives: Procedure: TAP Catheter and Infusion of Study Solution |
| Single injection with Ropivicaine infused TAP catheter | Active comparator | Prior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given 0.2% ropivicaine in infusion pump, attached to catheter Receives: Procedure: TAP Catheter and Infusion of Study Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain.
Measured: 1 day
Secondary outcomes (4)
Pain with movement on second day following surgery, as measured by 0-10 scale (where 0=no pain and 10=worst imaginable pain).
Measured: 2 days
Total opioid consumption per day following surgery as measured by the number of opioid pills consumed per day.
Measured: Day 1 and 2 following surgery
Sleep disturbances, measured on days 1 and 2 following surgery, as asked by research staff during follow-up phone calls.
Measured: Days 1 and 2 following surgery
Patient satisfaction of pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied with pain control
Measured: Day 2 following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Vanessa Loland, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944151
- Sponsor's protocol ID
- TAP Catheter
- Status last verified
- Jul 2009
- First submitted
- 21 Jul 2009
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00944151
- Acronym / sponsor ID
- TAP Catheter
- Conditions
- Incisional Pain
- Keywords
- pain, UCSD, catheter, nerve block, hernia, post-surgery pain, abdominal pain, pelvic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Jul 2009 (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.
Research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. This study will also help determine if patients require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their postoperative pain control.
Detailed description
Specific Aim: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in improved postoperative pain control.
Hypothesis 1: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in lower average pain scores during movement the day following surgery.
Specific Aim2: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, opioid use, sleep disturbances, and improved patient satisfaction.
Hypothesis 2: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, oral opioid consumption, sleep disturbances, and improved patient satisfaction the day following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single injection with Saline infused TAP catheter | Placebo comparator | Procedure: TAP Catheter and Infusion of Study SolutionPrior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given normal saline in infusion pump, attached to catheter. |
| Single injection with Ropivicaine infused TAP catheter | Active comparator | Procedure: TAP Catheter and Infusion of Study SolutionPrior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given 0.2% ropivicaine in infusion pump, attached to catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- undergoing ambulatory inguinal and/or abdominal surgery amenable to a Transversus Abdominis Plane nerve block (unilateral or bilateral).
- expected postoperative pain to be at least moderate in severity the day following surgery
- age 18 years or older
- desires a regional anesthetic for postoperative analgesia
- is able to understand the possible perineural infusion-related complications, study protocol, and catheter/pump care
Key exclusion criteria (11 listed)
- any contraindication for a continuous Transversus Abdominis Plane nerve block
- any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- current chronic opioid or tramadol use
- history of alcohol or opioid abuse
- know allergy or other contraindication to the study medication
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 and Infusion of Study SolutionSubject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in. | Procedure or surgery | Single injection with Ropivicaine infused TAP catheter, Single injection with Saline infused TAP catheter |
Primary outcome
The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain.
Time frame: 1 day
4 secondary outcomes
Pain with movement on second day following surgery, as measured by 0-10 scale (where 0=no pain and 10=worst imaginable pain).
Time frame: 2 days
Total opioid consumption per day following surgery as measured by the number of opioid pills consumed per day.
Time frame: Day 1 and 2 following surgery
Sleep disturbances, measured on days 1 and 2 following surgery, as asked by research staff during follow-up phone calls.
Time frame: Days 1 and 2 following surgery
Patient satisfaction of pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied with pain control
Time frame: Day 2 following surgery
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Vanessa Loland, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAP Catheter and Infusion of Study Solution in people with Incisional Pain, run by University of California, San Diego 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 7 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: stopped early, as of the sponsor's last update on 20 May 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). 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?
The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain. (time frame: 1 day). 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 20 May 2014.