Clinical trial NCT06214533: Celiac plExus Block to Reduce OpioID Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery
Official title: Celiac Plexus Block to Reduce Opioid Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Liver, Cancer of, Primary Resectable
Keywords: laparoscopic hepato-pancreato-biliary surgery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: A bilateral CPB is convenient and safe to perform under the direct laparoscopic vision of the surgeons during surgery; however, perspective data are warranted. The investigators hypothesize that a bilateral CPB using 0.5% ropivacaine will improve the quality of recovery following a laparoscopic hepato-pancreato-biliary surgery. The primary endpoint is the Postoperative opioid use. Secondary endpoints include acute postoperative pain, opioid consumption, the incidence of postoperative nausea or vomiting (PONV), the 15-item quality of recovery questionnaire (QoR-15), length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay, and chronic post-surgical pain at 90 d after surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid use
timeFrame: Up to 24 h after surgery
Secondary outcomes:
measure: Postoperative opioid use
timeFrame: Up to 72 h after surgery
measure: Numeric rating scale (NRS) for pain
timeFrame: Up to 72 h after surgery
measure: Postoperative vomiting
timeFrame: Up to 72 h after surgery
measure: Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15)
timeFrame: Up to 72 h after surgery
measure: Post-anesthesia care unit (PACU) time
timeFrame: Through study completion, an average of 1 year
measure: Post-operative hospital time
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Ruan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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: 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.
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.
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.
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.
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.
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.
citation: Penman ID. Coeliac plexus neurolysis. Best Pract Res Clin Gastroenterol. 2009;23(5):761-6. doi: 10.1016/j.bpg.2009.05.003.
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.
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.
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.
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.
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.
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.
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.
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.