Celiac plExus Block to Reduce OpioID Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery

Pancreatic Ductal Adenocarcinoma Clinical Trial

— CEBOIDS  

Official title:

Celiac Plexus Block to Reduce Opioid Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214533
• Other study ID #: 2022-090
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Liver Neoplasms
• Pancreatic Ductal Adenocarcinoma

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)

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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

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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

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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

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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

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* Note: There are 22 references in all — Click 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