RECRUITING

Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating Optimal Perioperative Pain Management: a Prospective Randomized Control Trial of Laparoscopic Transversus Abdominis Plane Block with Local Anesthetic, Laparoscopic Transversus Abdominis Plane Block Alone, and Local Anesthetic Alone in Minimally Invasive Oncologic Surgery

Quick Facts

Study Start:2025-01-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06731998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female patients age ≥ 18 - 89
  2. 2. Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
  3. 3. Patients who have provided informed consent to participate in the study.
  4. 4. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
  5. 5. Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
  6. 6. Patients able to understand and self-report pain using the designated pain Visual Analog Scale
  1. 1. Patients age less than 18 or ≥ 90
  2. 2. Pre-existing hepatic dysfunction, cirrhosis
  3. 3. Patients with an ASA classification of IV or higher.
  4. 4. Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
  5. 5. Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
  6. 6. Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
  7. 7. Patients unable to understand the language in which consent and study-related information are provided (The study and the study-related information will be in the English Language)..
  8. 8. Patients who have undergone major surgery within the last 6 months.
  9. 9. Female patients who are pregnant.
  10. 10. Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.

Contacts and Locations

Study Contact

Casey Allen, MD
CONTACT
(412) 913-6466
casey.allen@ahn.org
AHN Clinical Trials Contact
CONTACT
clinicaltrials@ahn.org

Principal Investigator

Casey Allen, MD
PRINCIPAL_INVESTIGATOR
Allegheny Health Network

Study Locations (Sites)

AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  • Casey Allen, MD, PRINCIPAL_INVESTIGATOR, Allegheny Health Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Laparoscopic Transversus Abdominis Plane Block
  • Local Anesthetic
  • Laparoscopic Surgical Procedure
  • pain management
  • cancer
  • cancer surgery
  • oncologic surgery
  • perioperative pain management
  • minimally invasive surgical procedures

Additional Relevant MeSH Terms

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