- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2025-01-13
2025-06
2025-12
48
NCT06731998
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
INTERVENTIONAL
Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery
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.
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.
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 | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-11-12 | N/A | 2025-01-15 |
2024-12-09 | N/A | 2025-01-17 |
2024-12-13 | N/A | 2024-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Laparoscopic Transversus Abdominis Plane Block with Local Anesthetic Patient would be receiving Laparoscopic Transversus Abdominis Plane block in addition to Local Anesthetic per standard of care. | PROCEDURE: Local Anesthesia
PROCEDURE: Laparoscopic Transversus Abdominis Plane block
|
| ACTIVE_COMPARATOR: Laparoscopic Transversus Abdominis Plane block only Patient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care. | PROCEDURE: Laparoscopic Transversus Abdominis Plane block
|
| ACTIVE_COMPARATOR: Local Anesthetic only Patient would be receiving Local Anesthetic per standard of care. | PROCEDURE: Local Anesthesia
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pain Score | 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. | Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption (milligrams) within the first 24 hours post-surgery (standardize with Morphine equivalence). | up to 24 hours post surgery |
| Recovery Analgesic Time | Time to first rescue analgesic request | up to 24 hours post surgery |
| Adverse Event(s) Frequency | Frequency of any adverse events related to interventions | immediately post surgery up through discharge (on average of 1 week) |
| Adverse Event(s) Severity | Severity of any adverse events related to interventions | immediately post surgery up through discharge (on average of 1 week) |
| Patient Satisfaction with Pain Management | 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. | At discharge (on average of 1 week) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Casey Allen, MD Phone Number: (412) 913-6466 Email: casey.allen@ahn.org |
Study Contact Backup Name: AHN Clinical Trials Contact Phone Number: Email: clinicaltrials@ahn.org |
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:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
