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

Primary Purpose

Pain, Postoperative, Nerve Block

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Celiac plexus block
Ropivacaine
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring celiac plexus block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; ④ Patients need to be cared in ICU after operation; ⑤ Allergic to amide local anesthetics. ⑥ Preoperative abdominal CT shows obvious anatomical variation of celiac ganglion; ⑦ Combined with abdominal aortic disease such as aneurysms.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NB group

GC group

Arm Description

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.

The same analgesic plan as the experimental group, except that CPB is not performed.

Outcomes

Primary Outcome Measures

Opioid consumption
Morphine equivalent

Secondary Outcome Measures

Time to first flatus
Pain scores
VAS (0 indicates no pain and score 10 indicates the most severe pain)
Blood pressure
Mean arterial pressure
Heart rate
Cardiac index
Systemic vascular resistance index

Full Information

First Posted
December 29, 2021
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05205720
Brief Title
Application of Celiac Plexus Block in Postoperative Analgesia of Upper Abdominal Surgery
Official Title
Application of Celiac Plexus Block in Postoperative Analgesia of Upper Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Nerve Block
Keywords
celiac plexus block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NB group
Arm Type
Experimental
Arm Description
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.
Arm Title
GC group
Arm Type
No Intervention
Arm Description
The same analgesic plan as the experimental group, except that CPB is not performed.
Intervention Type
Procedure
Intervention Name(s)
Celiac plexus block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Morphine equivalent
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
Time to first flatus
Time Frame
72 hours after surgery
Title
Pain scores
Description
VAS (0 indicates no pain and score 10 indicates the most severe pain)
Time Frame
6, 12, 24, 48, 72 hours after surgery
Title
Blood pressure
Description
Mean arterial pressure
Time Frame
Baseline and 5、10、20 minutes after CPB
Title
Heart rate
Time Frame
Baseline and 5、10、20 minutes after CPB
Title
Cardiac index
Time Frame
Baseline and 5、10、20 minutes after CPB
Title
Systemic vascular resistance index
Time Frame
Baseline and 5、10、20 minutes after CPB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; ④ Patients need to be cared in ICU after operation; ⑤ Allergic to amide local anesthetics. ⑥ Preoperative abdominal CT shows obvious anatomical variation of celiac ganglion; ⑦ Combined with abdominal aortic disease such as aneurysms.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minpu Li, Master
Phone
+8615257140348
Email
2520066@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minpu Li, Master
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minpu Li, Master
Phone
+8615257140348
Email
2520066@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers whose proposed use of the data has been approved.
IPD Sharing Time Frame
With publication

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

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