Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

Condition
Oncologic Surgery
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

AHN West Penn Hospital, Pittsburgh, Pennsylvania, United States, 15224

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male and female patients age ≥ 18 - 89
  • 2. Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
  • 3. Patients who have provided informed consent to participate in the study.
  • 4. Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
  • 5. Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
  • 6. Patients able to understand and self-report pain using the designated pain Visual Analog Scale
  • 1. Patients age less than 18 or ≥ 90
  • 2. Pre-existing hepatic dysfunction, cirrhosis
  • 3. Patients with an ASA classification of IV or higher.
  • 4. Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
  • 5. Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
  • 6. Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
  • 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. Patients who have undergone major surgery within the last 6 months.
  • 9. Female patients who are pregnant.
  • 10. Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute),

Casey Allen, MD, PRINCIPAL_INVESTIGATOR, Allegheny Health Network

Study Record Dates

2025-12