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

NCT06214533 | Unknown

• 1 other identifier: 2022-090
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pancreatic Ductal Adenocarcinoma; Liver, Cancer of, Primary Resectable

Keywords

laparoscopic hepato-pancreato-biliary surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid use

  The primary outcome will be morphine equivalent during the first postoperative 24 h

  Up to 24 h after surgery

Secondary Outcomes (6)

• Postoperative opioid use

  Up to 72 h after surgery

• Numeric rating scale (NRS) for pain

  Up to 72 h after surgery

• Postoperative vomiting

  Up to 72 h after surgery

• Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15)

  Up to 72 h after surgery

• Post-anesthesia care unit (PACU) time

  Through study completion, an average of 1 year

Study Arms (2)

Never block

EXPERIMENTAL

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. Intervention: Drug: 20 mL of 0.5% Ropivacaine

Drug: Ropivacaine 0.5%

Placebo block

PLACEBO COMPARATOR

Patients in the control arm will undergo the celiac plexus block procedure as well. The block will contain 20 ml of 0.9% normal saline + 1:400000 adrenaline. Intervention: Drug: 20 mL of 0.9% normal saline

Drug: Normal Saline

Interventions

Ropivacaine 0.5% DRUG

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.

Also known as: Naropin

Never block

Normal Saline DRUG

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.

Placebo block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over age 18
• Undergoing laparoscopic hepato-pancreato-biliary surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Related Publications (22)

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MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ruan

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu

CONTACT

+8613500000368; 1372351078@qq.com

Guo

CONTACT

+8613660859897; Jingguo17@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: January 19, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share