Postoperative PainPhase 3NCT02525900
ssTAP vs TAP Catheters in TAH
A Phase 3 study testing Wound Infiltration, TAP Blocks and TAP Catheters in people with Postoperative Pain, run by University of Arkansas at 1 site in United States.
Trial summary
Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Wound Infiltration, TAP Blocks and TAP Catheters
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2016to 5 Jun 2018
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo total abdominal hysterectomy
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status ≤ 3
Who cannot join
- Known coagulopathy
- Known allergy to Bupivacaine or morphine
- Contraindication to Tylenol usage
- Medical conditions contraindicated to bupivacaine use
- Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Comparing the Efficacy of Transversus Abdominis Plane Block, Both Single Injection and Continuous Block Technique, to Wound Infiltration for Total Abdominal Hysterectomy: A Prospective Randomized Study
Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).
- Conditions
- Postoperative Pain
- Being tested
- Wound Infiltration, TAP Blocks, TAP Catheters
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound InfiltrationProcedure or surgery
Wound Infiltration with 0.25% Bupivacine
TAP BlocksProcedure or surgery
bilateral TAP block with 0.25% Bupivacaine
TAP CathetersProcedure or surgery
bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Wound Infiltration | Placebo comparator | 0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration Receives: Procedure: Wound Infiltration |
| TAP Blocks | Experimental | 20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures Receives: Procedure: TAP Blocks |
| TAP Catheters | Experimental | 20mL of 0.25% bupivacaine will be injection on each side of the abdomen and catheters placed for repeat bolus every 12 hours with 20mL of 0.25% Bupivacine until 48 hours post procedure or hospital discharge. Receives: Procedure: TAP Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale.
The total morphine consumption used post operatively to manage pain will be measured utilizing the VAS pain scale with 0 being no pain and 10 being as much pain as can be tolerated.
Measured: Up to 48 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start12 Sep 2016
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Why it stopped: slow enrollment, and unusable data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Tingle, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525900
- Sponsor's protocol ID
- 204411
- Status last verified
- Jul 2018
- First submitted
- 14 Aug 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Transversus Abdominis Plane Block, Both Single Injection and Continuous Block Technique, to Wound Infiltration for Total Abdominal Hysterectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02525900
- Acronym / sponsor ID
- 204411
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, and unusable data
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 18 Aug 2015 (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.
Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wound Infiltration | Placebo comparator | Procedure: Wound Infiltration0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration |
| TAP Blocks | Experimental | Procedure: TAP Blocks20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures |
| TAP Catheters | Experimental | Procedure: TAP Catheters20mL of 0.25% bupivacaine will be injection on each side of the abdomen and catheters placed for repeat bolus every 12 hours with 20mL of 0.25% Bupivacine until 48 hours post procedure or hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo total abdominal hysterectomy
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) physical status ≤ 3
Key exclusion criteria (5 listed)
- Known coagulopathy
- Known allergy to Bupivacaine or morphine
- Contraindication to Tylenol usage
- Medical conditions contraindicated to bupivacaine use
- Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
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 |
|---|---|---|
| Wound InfiltrationWound Infiltration with 0.25% Bupivacine | Procedure or surgery | Wound Infiltration |
| TAP Blocksbilateral TAP block with 0.25% Bupivacaine | Procedure or surgery | TAP Blocks |
| TAP Cathetersbilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine | Procedure or surgery | TAP Catheters |
Primary outcome
Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale.
Time frame: Up to 48 hours post treatment
The total morphine consumption used post operatively to manage pain will be measured utilizing the VAS pain scale with 0 being no pain and 10 being as much pain as can be tolerated.
Results and safety
The study was stopped early (reason given: slow enrollment, and unusable data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sarah Tingle, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wound Infiltration, TAP Blocks and TAP Catheters in people with Postoperative Pain, run by University of Arkansas 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 5 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 9 Jul 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: slow enrollment, and unusable data). 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?
Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale. (time frame: Up to 48 hours post treatment). 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 9 Jul 2018.