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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06214533
Other study ID # 2022-090
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Hu
Phone +8613500000368
Email 1372351078@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine 0.5%
Prior to the end of the laparoscopic surgery and any additional procedures, the bilateral celiac plexus block will be performed by the surgeon after identification of the aorta at the superior border of body of pancreas. A 22-gauge spinal needle will be inserted into the retroperitoneal fat on either side of the aorta under direct vision. Needle aspiration will be performed to exclude entry into vessels before administration of the interventional drug. The block will contain 20 mL of 0.5% ropivacaine hydrochloride + 1:400000 adrenaline.
Normal Saline
Prior to the end of the laparoscopic surgery and any additional procedures, the bilateral celiac plexus block will be performed by the surgeon after identification of the aorta at the superior border of body of pancreas. A 22-gauge spinal needle will be inserted into the retroperitoneal fat on either side of the aorta under direct vision. Needle aspiration will be performed to exclude entry into vessels before administration of the interventional drug. The block will contain 20 ml of 0.9% normal saline + 1:400000 adrenaline.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

References & Publications (22)

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 allClick here to view all references

Outcome

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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