Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
Recruiting
Phase 4Interventional Study
AnalgesiaSurgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Supportive Care
Participants needed
80 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 (ab…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
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