Clinical trial NCT06731998: Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Score
timeFrame: Hourly, starting 1 hour post surgery for 24 hours, then at time of hospital discharge (on average 1 week)
Secondary outcomes:
measure: Opioid Consumption
timeFrame: up to 24 hours post surgery
measure: Recovery Analgesic Time
timeFrame: up to 24 hours post surgery
measure: Adverse Event(s) Frequency
timeFrame: immediately post surgery up through discharge (on average of 1 week)
measure: Adverse Event(s) Severity
timeFrame: immediately post surgery up through discharge (on average of 1 week)
measure: Patient Satisfaction with Pain Management
timeFrame: At discharge (on average of 1 week)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: Casey Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 17. https://pain.ucsf.edu/fascial-plane-blocks/transversus-abdominis-plane-tap-block
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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