Application of Celiac Plexus Block in Postoperative Analgesia of Whipple Surgery

This subject intends to explore the value of intraoperative celiac plexus block in postoperative acute pain management and its promoting effect on patients' rapid recovery during Whipple surgery through a randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Nerve Block
• Intervention / Treatment: Procedure: Celiac plexus block; Drug: Ropivacaine

Detailed Description

This study is a single center, randomized, single-blind controlled study. After calculating the sample size, 66 subjects would be randomly assigned to nerve block group (NB group: local anesthetic injection at the target position) and blank control group (GC group: no celiac plexus block) according to the ratio of 1:1, in order to evaluate the effectiveness and safety of celiac plexus block (CPB) as a part of multimodal analgesia for postoperative pain management.

Anesthesia protocol: the standard anesthesia protocol for open Whipple surgery in our hospital was adopted.

Postoperative analgesia plan: before abdominal closure at the end of operation, The surgeon was instructed to perform a single celiac plexus block (CPB) under direct vision. Ropivacaine was injected into the target nerve in NB group, but no injection in GC group. After the operation, the anesthesiologist used ropivacaine to perform ultrasound-guided abdominal wall nerve block. When leaving the operating room, connect intravenous analgesia pump. Patients with subjective pain score of 3 or above can press. If the analgesia is insufficient, intravenous injection of dezocine can be added temporarily. The intravenous analgesia pump shall be withdrawn after 72 hours of use. If the analgesia pump is used up and is still needed, the anesthesiologist can evaluate and add medicine.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age ≥ 18years;
2. received open Whipple surgery.

Exclusion Criteria:

1. patients unable to cooperate with evaluations;
2. patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases;
3. non-standard surgical procedures, planned postoperative ICU admission;
4. American Society of Anesthesiologists (ASA) classification of 4 or 5.

Withdrawal criteria:

Patients who underwent unplanned surgeries, required reintubation or a second surgery, received ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NB group; Celiac plexus block (CPB) was added to the postoperative analgesia plan. CPB: the target nerve is located in the retroperitoneal space, embedded in the fat in front of the aorta, and distributed in a network along the anterolateral wall of the aorta, just at the beginning of the celiac trunk. During direct vision (anterior) block, first expose the upper edge of the pancreas, palpate the abdominal aorta and abdominal trunk, and palpate the pulsation of the common hepatic artery and splenic artery at the level of the abdominal trunk. Use a 25g 6cm puncture needle with an extension tube and a syringe pumped back by an assistant to form a negative pressure, then the needle is inserted into the fat on both sides of the abdominal aorta. If there is no blood or fluid outflow, slowly inject 10ml of 0.5% ropivacaine each side. After pulling out the needle, observe whether there is damage and bleeding. If necessary, use low-energy electrocoagulation to stop bleeding.	Procedure: Celiac plexus block; The surgeon is instructed to perform a single celiac plexus block under direct vision. 10ml 0.5% ropivacaine is injected into the nerve in both sides.; Drug: Ropivacaine; Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.
No Intervention: GC group; The same analgesic plan as the experimental group, except that CPB is not performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Morphine equivalent	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first flatus		72 hours after surgery
Pain scores	VAS (0 indicates no pain and score 10 indicates the most severe pain)	6, 12, 24, 48, 72 hours after surgery
Press of the analgesic pump	Daily frequency of pump presses	Every 24 hours post-surgery for 72 hours
Length of postoperative hospitalization		After surgery to before discharge, up to 2 months
White blood cell count	Laboratory tests of white blood cell count (WBC)	At the end of surgery and 24 hours post-surgery
C-reactive protein	Laboratory tests of C-reactive protein (CRP)	At the end of surgery and 24 hours post-surgery
Erythrocyte sedimentation rate	Laboratory tests of erythrocyte sedimentation rate (ESR)	At the end of surgery and 24 hours post-surgery
Interleukin-6	Laboratory tests of interleukin-6 (IL-6)	At the end of surgery and 24 hours post-surgery
Procalcitonin	Laboratory tests of procalcitonin (PCT)	At the end of surgery and 24 hours post-surgery
Cardiac index changes during celiac plexus block	Celiac plexus block (CPB)	Before and 5、10、20 minutes after CPB
Systemic vascular resistance index changes during celiac plexus block	Celiac plexus block (CPB)	Before and 5、10、20 minutes after CPB
Postoperative mean arterial pressure	Mean arterial pressure (MAP)	Every 12 hours post-surgery for 72 hours
Postoperative heart rate	Heart rate (HR)	Every 12 hours post-surgery for 72 hours

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Health Commission of Zhejiang Province, China
• Investigators: Study Chair: Minpu Li, Master, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): November 12, 2023
• Study Completion (Actual): November 12, 2023

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: celiac plexus block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: 2021-0594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers whose proposed use of the data has been approved.
• IPD Sharing Time Frame: With publication
• IPD Sharing Supporting Information Type: SAP

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