Pain, PostoperativePhase 3NCT02652156
TAP Block for Postoperative Pain Control
A Phase 3 study testing Bupivacaine, Exparel® and Ropivacaine in people with Pain, Postoperative, run by Joshua Herskovic.
Trial summary
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine, Exparel® and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 16 Apr 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to give written informed consent
- Scheduled for open abdominal surgery
- American Society of Anesthesiologists physical status 1 to 3
Who cannot join
- Inability to understand the study or provide written informed consent
- Inability to follow protocol instructions
- Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
- Allergy to local anesthetic agents
- Contraindication to regional nerve block such as:
- Bleeding disorder
Show all 10Show fewer
- Sepsis
- Infection at site of block
- Body Mass Index (BMI) >40
- Pregnancy
About this study
Official title: Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine, Exparel®, Ropivacaine
- Keywords
- transversus abdominis plane, postoperative, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine, Sensorcaine
60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
Exparel®Drug
Also called bupivacaine liposome injectable suspension
20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
RopivacaineDrug
Also called Naropin
40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
| Study group | Role | What they receive |
|---|---|---|
| Single Injection of Bupivacaine | Active comparator | Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane. Receives: Drug: Bupivacaine |
| Single Injection of Exparel® | Active comparator | Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane Receives: Drug: Exparel® |
| Continuous infusion of Ropivacaine | Active comparator | Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Dosage of Narcotic
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
Measured: 3 postoperative days
Secondary outcomes (6)
Postoperative Vomiting (Events)
Total number of vomiting episodes over the three postoperative days.
Measured: 3 postoperative days
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Measured: Postoperative Day 1
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Measured: Postoperative Day 2
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Measured: Postoperative Day 3
Number of Days Required for a Patient to Get Out of Bed
Patients will be assessed each day following the day of surgery for the ability to get out of bed.
Measured: Assessed daily for up to 3 days post-surgery
Number of Days Required for a Patient to Walk Unassisted
Patients will be assessed each day following the day of surgery for the ability to walk unassisted
Measured: Assessed daily for up to 3 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start1 Nov 2015
- Primary completion16 Apr 2016
- Study completion16 Apr 2016
Why it stopped: Operational barriers at the site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Herskovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Herskovic, Midwestern Regional Medical Center
- Investigators
- Joshua Herskovic, MD, Principal investigator, Midwestern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652156
- Sponsor's protocol ID
- MZ2014035
- Status last verified
- Oct 2018
- First submitted
- 19 Nov 2015
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block Study for Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT02652156
- Acronym / sponsor ID
- MZ2014035
- Conditions
- Pain, Postoperative
- Keywords
- transversus abdominis plane, postoperative, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Operational barriers at the site.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Joshua HerskovicUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 16 Apr 2016 (actual)
- Study completion
- 16 Apr 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Injection of Bupivacaine | Active comparator | Drug: BupivacaineSubjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane. |
| Single Injection of Exparel® | Active comparator | Drug: Exparel®Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane |
| Continuous infusion of Ropivacaine | Active comparator | Drug: RopivacaineSubjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to give written informed consent
- Scheduled for open abdominal surgery
- American Society of Anesthesiologists physical status 1 to 3
Key exclusion criteria (10 listed)
- Inability to understand the study or provide written informed consent
- Inability to follow protocol instructions
- Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery
- Allergy to local anesthetic agents
- Contraindication to regional nerve block such as:
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 |
|---|---|---|
| BupivacaineAlso: Marcaine, Sensorcaine60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block. | Drug | Single Injection of Bupivacaine |
| Exparel®Also: bupivacaine liposome injectable suspension20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block. | Drug | Single Injection of Exparel® |
| RopivacaineAlso: Naropin40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side. | Drug | Continuous infusion of Ropivacaine |
Primary outcome
Total Dosage of Narcotic
Time frame: 3 postoperative days
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
6 secondary outcomes
Postoperative Vomiting (Events)
Time frame: 3 postoperative days
Patient Reported Pain by VAS Scale
Time frame: Postoperative Day 1
Patient Reported Pain by VAS Scale
Time frame: Postoperative Day 2
Patient Reported Pain by VAS Scale
Time frame: Postoperative Day 3
Number of Days Required for a Patient to Get Out of Bed
Time frame: Assessed daily for up to 3 days post-surgery
Number of Days Required for a Patient to Walk Unassisted
Time frame: Assessed daily for up to 3 days post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joshua Herskovic, MD principal investigator
Midwestern Regional Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine, Exparel® and Ropivacaine in people with Pain, Postoperative, run by Joshua Herskovic.
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 10 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Dosage of Narcotic (time frame: 3 postoperative days). 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 2 Nov 2018.