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

January 10, 2024 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Never block

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%
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.
Other Names:
  • Naropin
Placebo Comparator: Placebo block

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid use
Time Frame: Up to 24 h after surgery
The primary outcome will be morphine equivalent during the first postoperative 24 h
Up to 24 h after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative hospital time
Time Frame: Through study completion, an average of 1 year
Length of hospital stay
Through study completion, an average of 1 year
Postoperative opioid use
Time Frame: Up to 72 h after surgery
Patients will be recorded for up to 72 h postoperative opioid consumption.
Up to 72 h after surgery
Numeric rating scale (NRS) for pain
Time Frame: Up to 72 h after surgery
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
Postoperative vomiting
Time Frame: Up to 72 h after surgery
Incidence of postoeprative vomiting will be recorded for up to 72 h
Up to 72 h after surgery
Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15)
Time Frame: Up to 72 h after surgery
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
Post-anesthesia care unit (PACU) time
Time Frame: Through study completion, an average of 1 year
Length of PACU stay
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Ruan, The Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Ductal Adenocarcinoma

Clinical Trials on Ropivacaine 0.5%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe