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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Laparoscopic Transversus Abdominis Plane block only | Active Comparator | Patient would be receiving Laparoscopic Transversus Abdominis Plane block without Local Anesthetic per standard of care. |
|
| Local Anesthetic only | Active Comparator | Patient would be receiving Local Anesthetic per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption (milligrams) within the first 24 hours post-surgery (standardize with Morphine equivalence). | up to 24 hours post surgery |
| Recovery Analgesic Time | Time to first rescue analgesic request |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Casey Allen, MD | Contact | (412) 913-6466 | casey.allen@ahn.org | |
| AHN Clinical Trials Contact | Contact | 412-913-6466 | clinicaltrials@ahn.org |
| Name | Affiliation | Role |
|---|---|---|
| Casey Allen, MD | Allegheny Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHN West Penn Hospital | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 17. https://pain.ucsf.edu/fascial-plane-blocks/transversus-abdominis-plane-tap-block | ||
| 33122942 | 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. | |
| 26770326 |
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It is not necessary for the scope of the study to share IPD.
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|
| 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. |
|
| up to 24 hours post surgery |
| Adverse Event(s) Frequency | Frequency of any adverse events related to interventions | immediately post surgery up through discharge (on average of 1 week) |
| Adverse Event(s) Severity | Severity of any adverse events related to interventions | immediately post surgery up through discharge (on average of 1 week) |
| Patient Satisfaction with Pain Management | Will gauge patient perceptions of pain control and overall satisfaction with their treatment with a standardized Visual Analog Scale utilizing a zero to ten scale, with zero being completely dissatisfied and ten being completely satisfied. | At discharge (on average of 1 week) |
| 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. |
| 32502615 | 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. |
| 21296242 | 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. |
| 37863700 | 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. |
| 24575769 | 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. |
| 31649397 | 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. |
| 25088860 | 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. |
| 29026331 | 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. |
| 34621471 | 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. |
| 31903595 | Background | Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020 Jan;107(2):e70-e80. doi: 10.1002/bjs.11477. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001660 | Biliary Tract Diseases |
| D005767 | Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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