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Laparotomy plus Local Wound Anesthetic for Pain relief

Phase 4

Recruiting

Led By Sumer Wallace, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated to be within 72 hours post-surgery

Awards & highlights

Study Summary

This trial is being conducted to determine if a pain control method called preoperative transversus abdominis plane (TAP) analgesia is as effective as surgeon-initiated wound infiltration with local anesthesia

Who is the study for?

This trial is for individuals undergoing laparotomy surgery for gynecologic reasons. It's designed to compare two pain management techniques post-surgery. Participants should be eligible for the surgical procedure and not have conditions that would exclude them from safely receiving either of the pain control methods.Check my eligibility

What is being tested?

The study is testing if a preoperative pain block called TAP anesthesia can provide similar or better post-surgery outcomes compared to local anesthetic applied directly to the wound by the surgeon, in terms of pain control, hospital stay length, and recovery.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection site, possible nerve damage, bleeding or infection with TAP anesthesia; and localized numbness, allergic reactions or less effective pain relief with local anesthetics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can have a TAP block and have no allergies to anesthetics or past surgeries that change my belly's structure.

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I am having surgery for a gynecological reason through a cut down the middle of my belly at UW Hospital.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated to be within 72 hours post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated to be within 72 hours post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated to be within 72 hours post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery

Secondary outcome measures

Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay

Length of hospital stay, measured in hours from admission to time of discharge order placement

Mean postoperative pain score for the first 24 hours post-surgery

+7 more

Trial Design

2Treatment groups

Active Control

Group I: Laparotomy plus Local Wound AnestheticActive Control1 Intervention

Group II: TAP Block plus LaparotomyActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,466 Total Patients Enrolled

Sumer Wallace, MDPrincipal InvestigatorUW Carbone Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"Based on the information provided by clinicaltrials.gov, this particular study is not currently seeking new participants. The trial was initially listed on January 1st, 2024 and was last updated on January 9th, 2024. However, it's worth noting that there are presently 317 other ongoing clinical trials actively enrolling individuals at this time."

Answered by AI

What is the level of risk associated with performing Laparotomy along with Local Wound Anesthetic on patients?

"As this trial is in Phase 4, indicating that the treatment has already received approval, our team at Power rates the safety of Laparotomy plus Local Wound Anesthetic as a 3 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery

2024. "Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06213454.

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