Pain, PostoperativeTOTEMNCT04382859
TOTEM: Trial of TAP Block Effective Medications
A study testing Transversus abdominis plane (TAP) block with liposomal bupivacaine in people with Pain, Postoperative, run by Western Michigan University School of Medicine at 1 site in United States.
Trial summary
Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Transversus abdominis plane (TAP) block with liposomal bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to Feb 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
- English speaking
Who cannot join
- Known current malignancy
- Contraindication to medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Melinda Abernethy, MD, 919-260-9328, melnda.abernethy@med.wmich.edu
About this study
Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.
- Conditions
- Pain, Postoperative
- Being tested
- Transversus abdominis plane (TAP) block with liposomal bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) block with liposomal bupivacaineProcedure or surgery
Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).
| Study group | Role | What they receive |
|---|---|---|
| TAP block with liposomal bupivacaine | Active comparator | Active comparator Receives: Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine |
| TAP block with 0.25% bupivacaine | Other | Standard comparator Receives: Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating 1 hour post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Measured: 1 hour post operation
Pain rating 2 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Measured: 2 hours post operation
Pain rating 4 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Measured: 4 hours post operation
Pain rating 72 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Measured: 72 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Dec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Abernethy, Western Michigan University School of Medicine
- Investigators
- Melinda Abernethy, MD, Principal investigator, Western Michigan University Homer Stryker M.D. School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382859
- Sponsor's protocol ID
- WMed-2020-0601
- Acronym
- TOTEM
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOTEM: Trial of TAP Block Effective Medications
- ClinicalTrials.gov ID
- NCT04382859
- Acronym / sponsor ID
- TOTEM / WMed-2020-0601
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 11 May 2020 (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.
Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with liposomal bupivacaine | Active comparator | Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaineActive comparator |
| TAP block with 0.25% bupivacaine | Other | Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaineStandard comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
- English speaking
Key exclusion criteria (2 listed)
- Known current malignancy
- Contraindication to medications
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 |
|---|---|---|
| Transversus abdominis plane (TAP) block with liposomal bupivacaineTransversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7). | Procedure or surgery | TAP block with 0.25% bupivacaine, TAP block with liposomal bupivacaine |
Primary outcome
Pain rating 1 hour post operation
Time frame: 1 hour post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 2 hours post operation
Time frame: 2 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 4 hours post operation
Time frame: 4 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Pain rating 72 hours post operation
Time frame: 72 hours post operation
Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Melinda Abernethy, MD principal investigator
Western Michigan University Homer Stryker M.D. School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane (TAP) block with liposomal bupivacaine in people with Pain, Postoperative, run by Western Michigan University School of Medicine 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 2 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 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melinda Abernethy, MD ((919) 260-9328, melinda.abernethy@med.wmich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating 1 hour post operation (time frame: 1 hour post operation). The study lists 4 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 27 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.