Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery

NCT06731998 | Recruiting

• 1 other identifier: LapTAP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA)
2. 2.Laparoscopic Transversus Abdominis Plane Block (LapTAP) only
3. 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; Biliary Tract Cancer; Pancreatic Cancer Resectable; Gynecologic Cancers; Gastrointestinal Cancers; Colorectal Cancer; Minimally Invasive Surgical Procedures

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Opioid Consumption

  up to 24 hours post surgery

• Recovery Analgesic Time

  up to 24 hours post surgery

• Adverse Event(s) Frequency

  immediately post surgery up through discharge (on average of 1 week)

• Adverse Event(s) Severity

  immediately post surgery up through discharge (on average of 1 week)

• Patient Satisfaction with Pain Management

  At discharge (on average of 1 week)

Study Arms (3)

Laparoscopic Transversus Abdominis Plane Block with Local Anesthetic

ACTIVE COMPARATOR

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

Laparoscopic Transversus Abdominis Plane block only

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Transversus Abdominis Plane block

Local Anesthetic only

ACTIVE COMPARATOR

Patient would be receiving Local Anesthetic per standard of care.

Procedure: Local Anesthesia

Interventions

Local Anesthesia 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 with Local Anesthetic; Local Anesthetic only

Laparoscopic Transversus Abdominis Plane block 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 with Local Anesthetic; Laparoscopic Transversus Abdominis Plane block only

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients age ≥ 18 - 89
• Patients scheduled for elective (clinically indicated) hepatic, gastric, biliary, pancreatic, gynecologic, colorectal, other GI Minimally invasive oncologic surgery.
• Patients who have provided informed consent to participate in the study.
• Patients with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III.
• Patients undergoing procedures anticipated to last more than 1 hour but less than 8 hours.
• Patients able to understand and self-report pain using the designated pain Visual Analog Scale

You may not qualify if:

• Patients age less than 18 or ≥ 90
• Pre-existing hepatic dysfunction, cirrhosis
• Patients with an ASA classification of IV or higher.
• Patients with chronic pain disorders or on long-term opioid or analgesic therapy.
• Patients with known contraindications to the study drugs or procedures (e.g., allergy to LA or contraindications to LapTAP).
• Patients with cognitive impairments or psychiatric conditions that could interfere with pain assessment or understanding of informed consent.
• 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)..
• Patients who have undergone major surgery within the last 6 months.
• Female patients who are pregnant.
• Patients currently enrolled in another clinical trial that might interfere with the outcome measures of this study.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Related Publications (12)

• 17. https://pain.ucsf.edu/fascial-plane-blocks/transversus-abdominis-plane-tap-block

  BACKGROUND

• Jones JH, Aldwinckle R. Interfascial Plane Blocks and Laparoscopic Abdominal Surgery: A Narrative Review. Local Reg Anesth. 2020 Oct 23;13:159-169. doi: 10.2147/LRA.S272694. eCollection 2020.

  PMID: 33122942 BACKGROUND

• Guo Q, Li R, Wang L, Zhang D, Ma Y. Transversus abdominis plane block versus local anaesthetic wound infiltration for postoperative analgesia: A systematic review and meta-analysis. Int J Clin Exp Med. 2015 Oct 15;8(10):17343-52. eCollection 2015.

  PMID: 26770326 BACKGROUND

• Hamid HK, Emile SH, Saber AA, Ruiz-Tovar J, Minas V, Cataldo TE. Laparoscopic-Guided Transversus Abdominis Plane Block for Postoperative Pain Management in Minimally Invasive Surgery: Systematic Review and Meta-Analysis. J Am Coll Surg. 2020 Sep;231(3):376-386.e15. doi: 10.1016/j.jamcollsurg.2020.05.020. Epub 2020 Jun 2.

  PMID: 32502615 BACKGROUND

• Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

  PMID: 21296242 BACKGROUND

• Mannava S, Hafezi N, Turk F, Colgate C, Askegard-Giesmann J, Markel T, Horn N, Gray B. Transversus Abdominis Plane Block VS. Local Wound Infiltration for Elective Minimally Invasive Cholecystectomy in Children: A Prospective Randomized Trial. J Pediatr Surg. 2024 Jan;59(1):96-102. doi: 10.1016/j.jpedsurg.2023.09.020. Epub 2023 Sep 22.

  PMID: 37863700 BACKGROUND

• Calle GA, Lopez CC, Sanchez E, De Los Rios JF, Vasquez EM, Serna E, Arango AM, Castaneda JD, Vasquez RA, Gonzalez A, Escobar A, Almanza LA. Transversus abdominis plane block after ambulatory total laparoscopic hysterectomy: randomized controlled trial. Acta Obstet Gynecol Scand. 2014 Apr;93(4):345-50. doi: 10.1111/aogs.12351.

  PMID: 24575769 BACKGROUND

• Rajanbabu A, Puthenveettil N, Appukuttan A, Asok A. Efficacy of laparoscopic-guided transversus abdominis plane block for patients undergoing robotic-assisted gynaecologic surgery: A randomised control trial. Indian J Anaesth. 2019 Oct;63(10):841-846. doi: 10.4103/ija.IJA_471_19. Epub 2019 Oct 10.

  PMID: 31649397 BACKGROUND

• El Hachem L, Small E, Chung P, Moshier EL, Friedman K, Fenske SS, Gretz HF 3rd. Randomized controlled double-blind trial of transversus abdominis plane block versus trocar site infiltration in gynecologic laparoscopy. Am J Obstet Gynecol. 2015 Feb;212(2):182.e1-9. doi: 10.1016/j.ajog.2014.07.049. Epub 2014 Aug 1.

  PMID: 25088860 BACKGROUND

• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

  PMID: 29026331 BACKGROUND

• Ye SP, Zhu WQ, Huang ZX, Liu DN, Wen XQ, Li TY. Role of minimally invasive techniques in gastrointestinal surgery: Current status and future perspectives. World J Gastrointest Surg. 2021 Sep 27;13(9):941-952. doi: 10.4240/wjgs.v13.i9.941.

  PMID: 34621471 BACKGROUND

• Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477.

  PMID: 31903595 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Liver Neoplasms; Biliary Tract Neoplasms; Gastrointestinal Neoplasms; Colorectal Neoplasms; Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Casey Allen, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Allen, MD

CONTACT

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

AHN Clinical Trials Contact

CONTACT

412-913-6466; clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Surgical Oncologist

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 13, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)