Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT06731998
Status
Recruiting
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Conditions

  • Biliary Tract Cancer
  • Cancer
  • Cancer Surgery
  • Colorectal Cancer
  • Gastric (Cardia, Body) Cancer
  • Gastrointestinal Cancers
  • Gynecologic Cancers
  • Hepatic Cancer
  • Minimally Invasive Surgical Procedures
  • Oncologic Surgery
  • Pancreatic Cancer Resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Local Anesthesia — PROCEDURE
    For local anesthetic administration at port sites, 30 mL of 0.1% ropivacaine is injected around the umbilical port site following the completion of the primary surgical procedure. Additionally, 5 mL of 0.1% ropivacaine is injected around each additional port site to ensure effective local anesthesia.
  • Laparoscopic Transversus Abdominis Plane block — PROCEDURE
    Surgeon will place 18 gauge needle into the fascial plane between the internal oblique and transversus abdominis muscles. Once the needle is accurately positioned surgeon will inject 15 mL of 0.1% ropivacaine slowly. This procedure is performed bilaterally to ensure comprehensive analgesia. The total volume utilized for the LapTAP block is 30 mL of 0.1% ropivacaine.

Study Details

This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered "Research" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery: 1. Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA) 2. Laparoscopic Transversus Abdominis Plane Block (LapTAP) only 3. Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.

Key Dates

Start date
Feb 5, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Laparoscopic Transversus Abdominis Plane Block with Local Anesthetic
    Patient would be receiving Laparoscopic Transversus Abdominis Plane block in addition to Local Anesthetic per standard of care.
  • Active Comparator: Laparoscopic Transversus Abdominis Plane block only
    Patient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care.
  • Active Comparator: Local Anesthetic only
    Patient would be receiving Local Anesthetic per standard of care.

Primary Outcome Measure

Pain Score [ Time Frame: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AHN West Penn HospitalPittsburghPennsylvania15224
Casey Allen, MD
[email protected]
(412) 913-6466
AHN Clinical Trials Contact
[email protected]
Casey J Allen, MD (PRINCIPAL_INVESTIGATOR)
Joseph Edward, MD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

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By specialty
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By research site
AHN West Penn Hospital· Pittsburgh, PA

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