RecruitingNot ApplicableNCT06731998

Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

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

Sponsor

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

Enrollment

48 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

Gynecologic Cancers Biliary Tract Cancer Cancer Gastrointestinal Cancers Hepatic Cancer Oncologic Surgery Cancer Surgery Gastric (Cardia, Body) Cancer Pancreatic Cancer Resectable

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria6

Male and female patients age ≥ 18 - 89
Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
Patients who have provided informed consent to participate in the study.
Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
Patients able to understand and self-report pain using the designated pain Visual Analog Scale

Exclusion Criteria10

Patients age less than 18 or ≥ 90
Pre-existing hepatic dysfunction, cirrhosis
Patients with an ASA classification of IV or higher.
Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
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)..
Patients who have undergone major surgery within the last 6 months.
Female patients who are pregnant.
Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.

Interventions

PROCEDURELocal Anesthesia

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.

PROCEDURELaparoscopic Transversus Abdominis Plane block

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.