Application of Celiac Plexus Block in Postoperative Analgesia of Upper Abdominal Surgery

Pain, Postoperative Clinical Trial

Official title:

Application of Celiac Plexus Block in Postoperative Analgesia of Upper Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205720
• Other study ID #: 2021-0594
• Status: Recruiting
• Phase: Phase 4
• Start date: March 9, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Minpu Li, Master
• Phone: +8615257140348
• Email: 2520066[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 epigastric laparotomy through a randomized controlled trial.

Description:

This study is a single center, randomized, double-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 upper abdominal 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 lower costal oblique transverse abdominal muscle plane nerve block (tapb) and rectus abdominis posterior sheath 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 The intravenous analgesia pump shall be withdrawn after 72 hours of use.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will accept open upper abdominal surgery and requiring intestinal anastomosis.

Exclusion Criteria:

• Patients cannot cooperate with pain assessment;
• Patients with analgesic drug abuse;
• Patients with other operations in the same period; ? Patients need to be cared in ICU after operation; ? Allergic to amide local anesthetics. ? Preoperative abdominal CT shows obvious anatomical variation of celiac ganglion; ? Combined with abdominal aortic disease such as aneurysms.

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Morphine equivalent	72 hours after surgery
Secondary	Time to first flatus		72 hours after surgery
Secondary	Pain scores	VAS (0 indicates no pain and score 10 indicates the most severe pain)	6, 12, 24, 48, 72 hours after surgery
Secondary	Blood pressure	Mean arterial pressure	Baseline and 5?10?20 minutes after CPB
Secondary	Heart rate		Baseline and 5?10?20 minutes after CPB
Secondary	Cardiac index		Baseline and 5?10?20 minutes after CPB
Secondary	Systemic vascular resistance index		Baseline and 5?10?20 minutes after CPB