Recruiting

LapTAP, LA, LA Only

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT06731998

Conditions

Oncologic Surgery

Cancer

Cancer Surgery

Hepatic Cancer

Gastric (Cardia, Body) Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Local Anesthesia

Laparoscopic Transversus Abdominis Plane block

Study Details

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.

Conditions

Oncologic Surgery

Cancer

Cancer Surgery

Hepatic Cancer

Gastric (Cardia, Body) Cancer

Study ID

NCT06731998

Start date

Feb 5, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Laparoscopic Transversus Abdominis Plane block only

Patient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care.

active comparator: Local Anesthetic only

Patient would be receiving Local Anesthetic per standard of care.

Interventions

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.

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.

Primary outcome measure

  • Pain Score [ Time Frame: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week) ]

Central Contacts and Locations

Central contacts

Casey Allen, MD

(412) 913-6466casey.allen@ahn.org

AHN Clinical Trials Contact

412-913-6466clinicaltrials@ahn.org

Locations

AHN West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Casey Allen, MD

(412) 913-6466casey.allen@ahn.org

AHN Clinical Trials Contact

clinicaltrials@ahn.org

Principal Investigator:

Casey J Allen, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2025-09-18.