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
Conditions
Keywords
Laparoscopic Transversus Abdominis Plane Block, Local Anesthetic, Laparoscopic Surgical Procedure, pain management, cancer, cancer surgery, oncologic surgery, perioperative pain management, minimally invasive surgical procedures
Brief 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.
Detailed description
Traditional pain management strategies have heavily relied on the use of Local Anesthesia (LA). Laparoscopic Transversus Abdominis Plane block (LapTAP) has emerged as a new approach for postoperative pain control following minimally invasive surgery, promising enhanced pain control in comparison with traditional approaches. Preliminary investigations into LapTAP have shown promise, yet there remains a significant gap in comparative effectiveness research, especially juxtaposed against the more traditional LA. We propose a comprehensive three-arm superiority trial evaluating LapTAP in conjunction with LA, LapTAP alone, and LA alone. We intend to scrutinize the efficacy of each modality in managing postoperative pain specific to minimally invasive oncologic surgery. Findings from this trial will be used to refine clinical protocols, improve patient outcomes, and potentially standardize care in postoperative pain management for minimally invasive oncologic procedures.
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.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week) | Pain will be measured in the post anesthesia care unit (PACU) using Visual Analog Scale. Pain will be scored from zero to ten, with zero being no pain at all and ten being unbearable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | up to 24 hours post surgery | Opioid consumption (milligrams) within the first 24 hours post-surgery (standardize with Morphine equivalence). |
| Recovery Analgesic Time | up to 24 hours post surgery | Time to first rescue analgesic request |
| Adverse Event(s) Frequency | immediately post surgery up through discharge (on average of 1 week) | Frequency of any adverse events related to interventions |
| Adverse Event(s) Severity | immediately post surgery up through discharge (on average of 1 week) | Severity of any adverse events related to interventions |
| Patient Satisfaction with Pain Management | At discharge (on average of 1 week) | Will gauge patient perceptions of pain control and overall satisfaction with their treatment with a standardized Visual Analog Scale utilizing a zero to ten scale, with zero being completely dissatisfied and ten being completely satisfied. |
Countries
United States
Contacts
Primary ContactCasey Allen, MD
Backup ContactAHN Clinical Trials Contact
Outcome results
None listed