Trials / Recruiting

RecruitingNCT06731998

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 48 (estimated)

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
Sex: All
Age: 18 Years – 89 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Local 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.
PROCEDURE	Laparoscopic 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.

Timeline

Start date: 2025-02-05
Primary completion: 2026-06-01
Completion: 2026-12-01
First posted: 2024-12-13
Last updated: 2025-09-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06731998. Inclusion in this directory is not an endorsement.