Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

NCT ID: NCT06731998

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-12-31

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.

Conditions

Oncologic Surgery; Cancer; Cancer Surgery; Hepatic Cancer; Gastric (Cardia, Body) Cancer; Biliary Tract Cancer; Pancreatic Cancer Resectable; Gynecologic Cancers; Gastrointestinal Cancers; Colorectal Cancer; Minimally Invasive Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Local Anesthesia

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Laparoscopic Transversus Abdominis Plane block only

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

Group Type: ACTIVE_COMPARATOR

Laparoscopic Transversus Abdominis Plane block

Intervention Type: PROCEDURE

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.

Local Anesthetic only

Patient would be receiving Local Anesthetic per standard of care.

Group Type: ACTIVE_COMPARATOR

Local Anesthesia

Intervention Type: PROCEDURE

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.

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Casey Allen, MD

Assistant Professor, Surgical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Casey Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Allegheny Health Network

Locations

AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Casey Allen, MD

Role: CONTACT

casey.allen@ahn.org

(412) 913-6466

AHN Clinical Trials Contact

Role: CONTACT

clinicaltrials@ahn.org

412-913-6466

Facility Contacts

Casey Allen, MD

Role: primary

casey.allen@ahn.org

(412) 913-6466

AHN Clinical Trials Contact

Role: backup

clinicaltrials@ahn.org

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33122942 (View on PubMed)

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Other Identifiers

LapTAP

Identifier Type: -

Identifier Source: org_study_id