What this study is
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.
What's being tested
- Local Anesthesia
Intervention · 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
Intervention · 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
- 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
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- 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
- Enrolling
- 48 people
- Starts
- 2025-02-05
- Est. completion
- 2026-12
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openAHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
- Casey Allen, MD · Contact(412) 913-6466casey.allen@ahn.org
- AHN Clinical Trials Contact · Contactclinicaltrials@ahn.org
- Casey J Allen, MD · Principal investigator
- Joseph Edward, MD · Sub-investigator
Recruiting
Study team
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID LapTAP
Principal investigator
Casey Allen, MD
Allegheny Health Network
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.