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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Pancreatic Ductal Adenocarcinoma; Liver, Cancer of, Primary Resectable

Treatments: Drug: Ropivacaine 0.5%; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06214533

2022-090

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Never block

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 0.5%

Placebo block

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline