Acute PainNCT01848951
Comparison of Epidural and TAP Block in Abdominal Surgery
An observational study of Acute Pain and Surgery, run by University of Nebraska at 1 site in United States.
Trial summary
This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Pain, Surgery, Regional Anesthesia
- What is being tested?
- Epidural and TAP Block
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to 1 Dec 2016
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects undergoing major abdominal surgery
Who may be able to join
- subject >/= 19 years of age
- Undergoing major abdominal surgery
- able to provide written informed consent
Who cannot join
- chronic opioid use
- allergies to amide anesthetics
- inability to undergo general anesthesia
- pregnancy
- any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
- or evidence of gross neurological dysfunction of the lower extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery
This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.
Read the detailed description
This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.
- Conditions
- Acute Pain, Surgery, Regional Anesthesia
- Being tested
- Epidural, TAP Block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralDrug
Also called local anesthetic
The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.
TAP BlockDrug
Also called transversus abdominis plane, abdominal muscle anesthesia
The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2)
| Study group | Role | What they receive |
|---|---|---|
| Epidural | The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated. Receives: Drug: Epidural | |
| TAP Block | The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2) Receives: Drug: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Comparison of pain scores (0 = no pain to 10 = worst pain possible)
Measured: 96 hours post-op
Opioid Consumption in a 24-Hour period
A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions
Measured: 96 hours post-op
Secondary outcomes (3)
Comparison of 96-hour hospital stay costs
Comparison of 96-hour hospital stay cost between the interventions
Measured: 96 hours post-op
Comparison of urinary failure/catheter acquired infection rates
Comparison of urinary failure/catheter acquired infection rates between the interventions
Measured: 96 hours post-op
Comparison of hypotension rates
Comparison hypotension rates between the interventions
Measured: 96 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study start1 Feb 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas A Nicholas, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848951
- Sponsor's protocol ID
- 0287-13-FB
- Status last verified
- Nov 2023
- First submitted
- 25 Apr 2013
- Last updated
- 28 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01848951
- Acronym / sponsor ID
- 0287-13-FB
- Conditions
- Acute Pain, Surgery, Regional Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 8 May 2013 (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.
This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.
Detailed description
This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | – | Drug: EpiduralThe skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated. |
| TAP Block | – | Drug: TAP BlockThe skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects undergoing major abdominal surgery
Key inclusion criteria (3 listed)
- subject >/= 19 years of age
- Undergoing major abdominal surgery
- able to provide written informed consent
Key exclusion criteria (6 listed)
- chronic opioid use
- allergies to amide anesthetics
- inability to undergo general anesthesia
- pregnancy
- any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
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 |
|---|---|---|
| EpiduralAlso: local anestheticThe skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated. | Drug | Epidural |
| TAP BlockAlso: transversus abdominis plane, abdominal muscle anesthesiaThe skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2) | Drug | TAP Block |
Primary outcome
Pain scores
Time frame: 96 hours post-op
Comparison of pain scores (0 = no pain to 10 = worst pain possible)
Opioid Consumption in a 24-Hour period
Time frame: 96 hours post-op
A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions
3 secondary outcomes
Comparison of 96-hour hospital stay costs
Time frame: 96 hours post-op
Comparison of urinary failure/catheter acquired infection rates
Time frame: 96 hours post-op
Comparison of hypotension rates
Time frame: 96 hours post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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 A Nicholas, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Surgery, run by University of Nebraska 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: finished, as of the sponsor's last update on 28 Nov 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain scores (time frame: 96 hours post-op). The study lists 2 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 28 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.