Study Summary
This trial is comparing two methods of pain control after laparoscopic colorectal surgery to see which is more effective. Group 1 will get a small dose of drugs injected into the spinal fluid, while group 2 will get drugs injected near the nerves under a muscle.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: 72 hours after surgery
24 hours after surgery
cumulated oral morphine equivalent (OME)
48 hours after surgery
patient's satisfaction scores
72 hours after surgery
Visual Analog Scale pain scores
Opioids
Day 7
hospital stay
Hour 72
first ambulation
first flatus
opioid side effects
oral food
oral liquid
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
IT Injection
1 of 2
ESP Block
1 of 2
Active Control
126 Total Participants · 2 Treatment Groups
Primary Treatment: IT Injection · No Placebo Group · Phase 1 & 2
IT Injection
Drug
ActiveComparator Group · 1 Intervention: IT Injection · Intervention Types: DrugESP Block
Drug
ActiveComparator Group · 1 Intervention: ESP Block · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours after surgery
Who is running the clinical trial?
Indiana UniversityLead Sponsor
914 Previous Clinical Trials
775,705 Total Patients Enrolled
7 Trials studying Surgery
555 Patients Enrolled for Surgery
Amy McCutchan, MDPrincipal InvestigatorIndiana University School of Medicine
Eligibility Criteria
Age 18 - 80 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You prefer to have anesthesia in a specific part of your body for pain management after surgery.
Your body mass index (BMI) is below 40kg/m2.
References
- Levy, B F, M J Scott, W Fawcett, C Fry, and T A Rockall. 2011. “Randomized Clinical Trial of Epidural, Spinal or Patient-controlled Analgesia for Patients Undergoing Laparoscopic Colorectal Surgery”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.7545.
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- Kendall, Mark C., Lucas Alves, Lauren L. Traill, and Gildasio S. De Oliveira. 2020. “The Effect of Ultrasound-guided Erector Spinae Plane Block on Postsurgical Pain: A Meta-analysis of Randomized Controlled Trials”. BMC Anesthesiology. Springer Science and Business Media LLC. doi:10.1186/s12871-020-01016-8.
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- Koo, Chang-Hoon, Jin-Young Hwang, Hyun-Jung Shin, and Jung-Hee Ryu. 2020. “The Effects of Erector Spinae Plane Block in Terms of Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: A Meta-analysis of Randomized Controlled Trials”. Journal of Clinical Medicine. MDPI AG. doi:10.3390/jcm9092928.
- Borzellino, Giuseppe, Nader Kamal Francis, Olivier Chapuis, Evguenia Krastinova, Valérie Dyevre, and Michele Genna. 2016. “Role of Epidural Analgesia Within an ERAS Program After Laparoscopic Colorectal Surgery: A Review and Meta-analysis of Randomised Controlled Studies”. Surgery Research and Practice. Hindawi Limited. doi:10.1155/2016/7543684.
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- Vidal, E., H. Giménez, M. Forero, and M. Fajardo. 2018. “Bloqueo del plano del músculo erector espinal: estudio anatómico-cadavérico para determinar su mecanismo de acción”. Revista española de anestesiología y reanimación. Elsevier BV. doi:10.1016/j.redar.2018.07.004.
- Pedrazzani, Corrado, Nicola Menestrina, Margherita Moro, Gianluca Brazzo, Guido Mantovani, Enrico Polati, and Alfredo Guglielmi. 2016. “Local Wound Infiltration Plus Transversus Abdominis Plane (TAP) Block Versus Local Wound Infiltration in Laparoscopic Colorectal Surgery and ERAS Program”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-016-4862-5.
- Altıparmak, Başak, Melike Korkmaz Toker, Ali Ihsan Uysal, Yağmur Kuşçu, and Semra Gümüş Demirbilek. 2019. “Ultrasound-guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Cholecystectomy: Randomized, Controlled Trial”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2019.03.012.
- Day, A R, R V P Smith, M J P Scott, W J Fawcett, and T A Rockall. 2015. “Randomized Clinical Trial Investigating the Stress Response from Two Different Methods of Analgesia After Laparoscopic Colorectal Surgery”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.9936.
- Tsui, Ban C.H., Ahtziri Fonseca, Farrukh Munshey, Grant McFadyen, and Thomas J. Caruso. 2019. “The Erector Spinae Plane (ESP) Block: A Pooled Review of 242 Cases”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2018.09.036.
- De Cassai, Alessandro, Daniele Bonvicini, Christelle Correale, Ludovica Sandei, Serkan Tulgar, and Tommaso Tonetti. 2019. “Erector Spinae Plane Block: A Systematic Qualitative Review”. Minerva Anestesiologica. Edizioni Minerva Medica. doi:10.23736/s0375-9393.18.13341-4.
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- Schwartzmann, Ana, Philip Peng, Mariano Antunez Maciel, Paola Alcarraz, Ximena Gonzalez, and Mauricio Forero. 2020. “A Magnetic Resonance Imaging Study of Local Anesthetic Spread in Patients Receiving an Erector Spinae Plane Block”. Canadian Journal of Anesthesia/journal Canadien D'anesthésie. Springer Science and Business Media LLC. doi:10.1007/s12630-020-01613-8.
- Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
- Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
- Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
- Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
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- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Koning MV, Klimek M, Rijs K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal surgery: a meta-analysis, meta-regression, and trial sequential analysis. Br J Anaesth. 2020 Sep;125(3):358-372. doi: 10.1016/j.bja.2020.05.061. Epub 2020 Jul 11.
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- Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22.
- Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- Koo CH, Hwang JY, Shin HJ, Ryu JH. The Effects of Erector Spinae Plane Block in Terms of Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 10;9(9):2928. doi: 10.3390/jcm9092928.
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Borzellino G, Francis NK, Chapuis O, Krastinova E, Dyevre V, Genna M. Role of Epidural Analgesia within an ERAS Program after Laparoscopic Colorectal Surgery: A Review and Meta-Analysis of Randomised Controlled Studies. Surg Res Pract. 2016;2016:7543684. doi: 10.1155/2016/7543684. Epub 2016 Aug 24.
- Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26.
- Amy McCutchan 2022. "ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257941.
Frequently Asked Questions
Are there any available positions for volunteers in this experiment?
"Yes, this information is accurate. The latest update on clinicaltrials.gov was on February 22nd, 2022 and the trial is still recruiting patients that match the eligibility criteria." - Anonymous Online Contributor
Unverified Answer
How can I become a part of this research project?
"This clinical study is looking for 126 individuals who are between 18 and 80 years old and have already undergone surgery. In addition, patients must also meet the following requirements: they must be undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital, they must have a BMI of less than 40kg/m2, they must desire regional anesthesia for postoperative pain control, and they must be ASA Class 1, 2, or 3 according to the American Society of Anesthesiologists physical status classification system." - Anonymous Online Contributor
Unverified Answer
Are participants in this trial required to be of majority age?
"Eligibility for this study includes patients aged 18-80. In total, there are 32 clinical trials underway involving patients that are minors and 246 with elderly participants." - Anonymous Online Contributor
Unverified Answer
How many people are being asked to participate in this research project?
"Yes, that is accurate. The clinical trial described was posted on January 27th and is currently looking for 126 patients at a single site." - Anonymous Online Contributor
Unverified Answer