Pancreatic Ductal Adenocarcinoma Clinical Trial
— CEBOIDSOfficial title:
Celiac Plexus Block to Reduce Opioid Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery: a Randomized Controlled Trial
The goal of this study is to assess the efficacy of intraoperative celiac plexus block (CPB) to reduce opioid consumption following laparoscopic hepato-pancreato-biliary surgery
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Over age 18 - Undergoing laparoscopic hepato-pancreato-biliary surgery Exclusion Criteria: - Patient refuse - Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history - Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment - Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months - Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sixth Affiliated Hospital, Sun Yat-sen University |
Al Samaraee A, Rhind G, Saleh U, Bhattacharya V. Factors contributing to poor post-operative abdominal pain management in adult patients: a review. Surgeon. 2010 Jun;8(3):151-8. doi: 10.1016/j.surge.2009.10.039. Epub 2010 Feb 12. — View Citation
Allen PJ, Chou J, Janakos M, Strong VE, Coit DG, Brennan MF. Prospective evaluation of laparoscopic celiac plexus block in patients with unresectable pancreatic adenocarcinoma. Ann Surg Oncol. 2011 Mar;18(3):636-41. doi: 10.1245/s10434-010-1372-x. Epub 2010 Oct 17. — View 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. — View Citation
Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526. — View Citation
Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606. — View Citation
Kretzschmar M, Krause J, Palutke I, Schirrmeister W, Schramm H. [Intraoperative neurolysis of the celiac plexus in patients with unresectable pancreatic cancer]. Zentralbl Chir. 2003 May;128(5):419-23. doi: 10.1055/s-2003-40039. German. — View Citation
Ladha KS, Patorno E, Huybrechts KF, Liu J, Rathmell JP, Bateman BT. Variations in the Use of Perioperative Multimodal Analgesic Therapy. Anesthesiology. 2016 Apr;124(4):837-45. doi: 10.1097/ALN.0000000000001034. — View Citation
Lavu H, Lengel HB, Sell NM, Baiocco JA, Kennedy EP, Yeo TP, Burrell SA, Winter JM, Hegarty S, Leiby BE, Yeo CJ. A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. J Am Coll Surg. 2015 Apr;220(4):497-508. doi: 10.1016/j.jamcollsurg.2014.12.013. Epub 2014 Dec 17. — View Citation
Lillemoe KD, Cameron JL, Kaufman HS, Yeo CJ, Pitt HA, Sauter PK. Chemical splanchnicectomy in patients with unresectable pancreatic cancer. A prospective randomized trial. Ann Surg. 1993 May;217(5):447-55; discussion 456-7. doi: 10.1097/00000658-199305010-00004. — View Citation
Liu S, Fu W, Liu Z, Liu M, Ren R, Zhai H, Li C. MRI-guided celiac plexus neurolysis for pancreatic cancer pain: Efficacy and safety. J Magn Reson Imaging. 2016 Oct;44(4):923-8. doi: 10.1002/jmri.25246. Epub 2016 Mar 28. — View Citation
McLeod RS, Aarts MA, Chung F, Eskicioglu C, Forbes SS, Conn LG, McCluskey S, McKenzie M, Morningstar B, Nadler A, Okrainec A, Pearsall EA, Sawyer J, Siddique N, Wood T. Development of an Enhanced Recovery After Surgery Guideline and Implementation Strategy Based on the Knowledge-to-action Cycle. Ann Surg. 2015 Dec;262(6):1016-25. doi: 10.1097/SLA.0000000000001067. — View Citation
Penman ID. Coeliac plexus neurolysis. Best Pract Res Clin Gastroenterol. 2009;23(5):761-6. doi: 10.1016/j.bpg.2009.05.003. — View Citation
Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, Wong J. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Ann Surg. 2001 Jul;234(1):63-70. doi: 10.1097/00000658-200107000-00010. — View Citation
Revie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x. — View Citation
Sakorafas GH, Tsiotou AG, Sarr MG. Intraoperative celiac plexus block in the surgical palliation for unresectable pancreatic cancer. Eur J Surg Oncol. 1999 Aug;25(4):427-31. doi: 10.1053/ejso.1999.0670. No abstract available. — View Citation
Sommer M, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Geurts JW, Gramke HF, Marcus MA. The prevalence of postoperative pain in a sample of 1490 surgical inpatients. Eur J Anaesthesiol. 2008 Apr;25(4):267-74. doi: 10.1017/S0265021507003031. Epub 2007 Dec 6. — View Citation
Strong VE, Dalal KM, Malhotra VT, Cubert KH, Coit D, Fong Y, Allen PJ. Initial report of laparoscopic celiac plexus block for pain relief in patients with unresectable pancreatic cancer. J Am Coll Surg. 2006 Jul;203(1):129-31. doi: 10.1016/j.jamcollsurg.2006.03.020. Epub 2006 May 30. No abstract available. — View Citation
Tan M, Law LS, Gan TJ. Optimizing pain management to facilitate Enhanced Recovery After Surgery pathways. Can J Anaesth. 2015 Feb;62(2):203-18. doi: 10.1007/s12630-014-0275-x. Epub 2014 Dec 10. — View Citation
Teo ZHT, Tey BLJ, Foo CW, Wong WY, Low JK. Intraoperative Celiac Plexus Block With Preperitoneal Infusion Reduces Opioid Usage in Major Hepato-pancreato-biliary Surgery: A Pilot Study. Ann Surg. 2021 Jul 1;274(1):e97-e99. doi: 10.1097/SLA.0000000000004883. — View Citation
Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191. — View Citation
Wyse JM, Carone M, Paquin SC, Usatii M, Sahai AV. Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. J Clin Oncol. 2011 Sep 10;29(26):3541-6. doi: 10.1200/JCO.2010.32.2750. Epub 2011 Aug 15. — View Citation
Zhu J, Jin Z. Interventional Therapy for Pancreatic Cancer. Gastrointest Tumors. 2016 Oct;3(2):81-89. doi: 10.1159/000446800. Epub 2016 Sep 6. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative opioid use | The primary outcome will be morphine equivalent during the first postoperative 24 h | Up to 24 h after surgery | |
Secondary | Postoperative opioid use | Patients will be recorded for up to 72 h postoperative opioid consumption. | Up to 72 h after surgery | |
Secondary | Numeric rating scale (NRS) for pain | Patients will be asked to complete a daily diary up to 72 h that records numeric pain rating scale | Up to 72 h after surgery | |
Secondary | Postoperative vomiting | Incidence of postoeprative vomiting will be recorded for up to 72 h | Up to 72 h after surgery | |
Secondary | Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15) | Patients will be asked to complete a 15-item quality of recovery questionnaire up to 72 h after surgery | Up to 72 h after surgery | |
Secondary | Post-anesthesia care unit (PACU) time | Length of PACU stay | Through study completion, an average of 1 year | |
Secondary | Post-operative hospital time | Length of hospital stay | Through study completion, an average of 1 year |
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