Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

Not Applicable

Recruiting

• Conditions: Minimally Invasive Surgical Procedures; Oncologic Surgery; Cancer; Cancer Surgery; Hepatic Cancer; Gastric (cardia, Body) Cancer; Biliary Tract Cancer; Pancreatic Cancer Resectable; Gynecologic Cancers; Gastrointestinal Cancers

• Registration Number: NCT06731998
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-13
• Study Start: 2025-01-13
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AHN West Penn Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States