AnalgesiaPhase 4NCT06213454
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
A Phase 4 study testing TAP Anesthesia and Surgeon-Initiated Local Anesthetic in people with Analgesia and Surgery, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- TAP Anesthesia and Surgeon-Initiated Local Anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 10 Sep 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
- Patients must be >18 years old
- English speaking (able to provide consent and complete questionnaires)
- Patients must have the ability to understand visual and verbal pain scales
- Patients must be eligible for TAP block placement. This will be confirmed during preoperative visit with the primary surgeon. Patient's are not eligible if they have allergies to the anesthetic medications or have had prior abdominal reconstructive surgery that would alter their abdominal wall anatomy in a way where the block would not be expected to be effective.
Who cannot join
- Known allergy to local anesthetics.
- Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
- Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
- Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
- Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
- Significant liver disease that would inhibit prescription of opioids.
- Significant kidney disease that would inhibit administration of gabapentin.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, 53726
About this study
This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.
Read the detailed description
Primary Objective
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy.
Secondary Objectives
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
- To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
- Being tested
- TAP Anesthesia, Surgeon-Initiated Local Anesthetic
- Keywords
- laparotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP AnesthesiaDrug
Also called bupivacaine, liposomal bupivacaine
ultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections
Surgeon-Initiated Local AnestheticDrug
266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound
| Study group | Role | What they receive |
|---|---|---|
| TAP Block plus Laparotomy | Active comparator | Not described Receives: Drug: TAP Anesthesia |
| Laparotomy plus Local Wound Anesthetic | Active comparator | Not described Receives: Drug: Surgeon-Initiated Local Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).
Measured: 24 hours post-surgery
Secondary outcomes (10)
Mean postoperative pain score for the first 24 hours post-surgery
Mean postoperative pain score for the first 24 hours post-surgery, measured by the Numeric Rating Scale (NRS), which rates pain on a 0-10 scale (collected routinely on the post-operative floor). Higher numbers indicate worse pain.
Measured: 24 hours post-surgery
Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement
Measured: estimated to be up to 3 days
Post-operative anti-emetic use
A study team member will review the patient's medical chart to record the number of times an anti-emetic was given to the subject.
Measured: estimated to be up to 3 days
Number of recorded episodes of emesis
A study team member will review the patient's medical chart to record number of times the hospital staff observed a participant vomit.
Measured: estimated to be up to 3 days
Return of bowel function measured in whole hours from completion of surgery to passage of flatus
Measured: estimated to be up to 3 days
Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score
Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.
Measured: post-operative visit (up to 60 days)
Readmission rate measured by readmission in the 30 days following surgery
Measured: up to 30 days
Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay
Measured: estimated to be up to 3 days
Summary of Post-operative Complications
Postoperative complications, as defined by urinary tract infections, thromboembolic events, pneumonia, blood transfusion, cardiac events, falls, and electrolyte disturbances will be summarized by type and number of complications.
Measured: up to 30 days post-operatively
Time to First Ambulation measured in hours
A study team member will review the participant's medical chart to record the interval (in hours) from completion of surgery to first ambulation after surgery.
Measured: estimated to be within 72 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start26 Mar 2024
- Primary completion12 Aug 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, unblinded, single-center trial testing the hypothesis that surgeon-initiated wound infiltration with local anesthetic is non-inferior in providing postoperative pain control when compared with preoperative TAP analgesia.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumer Wallace, MD, Principal investigator, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213454
- Sponsor's protocol ID
- 2023-1099
- Other IDs
- UW23039, NCI-2023-10464, Protocol Version 7/17/2024, A532820
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
- ClinicalTrials.gov ID
- NCT06213454
- Acronym / sponsor ID
- 2023-1099
- Keywords
- laparotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 19 Jan 2024 (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.
This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.
Detailed description
Primary Objective
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy.
Secondary Objectives
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
- To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
- To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, unblinded, single-center trial testing the hypothesis that surgeon-initiated wound infiltration with local anesthetic is non-inferior in providing postoperative pain control when compared with preoperative TAP analgesia.
| Arm | Type | Receives |
|---|---|---|
| TAP Block plus Laparotomy | Active comparator | Drug: TAP Anesthesia |
| Laparotomy plus Local Wound Anesthetic | Active comparator | Drug: Surgeon-Initiated Local Anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
- Patients must be >18 years old
- English speaking (able to provide consent and complete questionnaires)
- Patients must have the ability to understand visual and verbal pain scales
Key exclusion criteria (8 listed)
- Known allergy to local anesthetics.
- Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
- Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
- Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
- Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
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 AnesthesiaAlso: bupivacaine, liposomal bupivacaineultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections | Drug | TAP Block plus Laparotomy |
| Surgeon-Initiated Local Anesthetic266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound | Drug | Laparotomy plus Local Wound Anesthetic |
Primary outcome
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery
Time frame: 24 hours post-surgery
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).
10 secondary outcomes
Mean postoperative pain score for the first 24 hours post-surgery
Time frame: 24 hours post-surgery
Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement
Time frame: estimated to be up to 3 days
Post-operative anti-emetic use
Time frame: estimated to be up to 3 days
Number of recorded episodes of emesis
Time frame: estimated to be up to 3 days
Return of bowel function measured in whole hours from completion of surgery to passage of flatus
Time frame: estimated to be up to 3 days
Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score
Time frame: post-operative visit (up to 60 days)
Readmission rate measured by readmission in the 30 days following surgery
Time frame: up to 30 days
Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay
Time frame: estimated to be up to 3 days
Summary of Post-operative Complications
Time frame: up to 30 days post-operatively
Time to First Ambulation measured in hours
Time frame: estimated to be within 72 hours post-surgery
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 29 Sep 2026.
- 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.
Sumer Wallace, MD principal investigator
UW Carbone Cancer Center
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 Anesthesia and Surgeon-Initiated Local Anesthetic in people with Analgesia and Surgery, run by University of Wisconsin, Madison 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 6 inclusion and 8 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 29 Sep 2026. 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.
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 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?
Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (time frame: 24 hours post-surgery). 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 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.