A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain

Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. >20% of patients suffer from chronic postoperative pain. China has >70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management.

Study Overview

• Status: Recruiting
• Conditions: Chronic Postoperative Pain
• Intervention / Treatment: Procedure: Echogenic nerve block needle; Procedure: Non-echogenic nerve block needle

Detailed Description

Surgical pain is one of the common complications after surgery, which seriously affects the recovery and treatment quality of patients. More than 20% of patients will suffer from postoperative chronic pain. According to the data of the National Bureau of Statistics, there are more than 70 million surgeries in China every year. Nerve block is one of the most commonly used methods for postoperative pain management in clinical practice. In recent years, the developing nerve block needle has gradually begun to be used in clinical practice. Compared with the ordinary non-developing nerve block needle, it may have a better effect on pain management after surgery, but whether it has a reduction effect on chronic pain after surgery is still unknown. The purpose of this study is to explore the effect of developing nerve block needle on postoperative pain, and to compare the difference between it and the common non-developing nerve block needle, so as to provide new ideas and methods for postoperative pain management.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Huang, ph.D; Phone Number: 13708385559; Email: huanghe@cqmu.edu.cn
• Study Contact Backup: Name: Da gang Wang, ph.D; Phone Number: 023 63693014; Email: kuanrenlunli@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 4000000
      • Recruiting
      • He Huang
      • Contact: He Huang, ph.D; Phone Number: 13708385559; Email: huanghe@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age is above 18 years old and below 70 years old.
2. patients whose surgical sites were in the chest, abdomen, upper limbs or lower limbs, including lobectomy, cholecystectomy, gastrointestinal resection, hysterectomy and other elective operations.
3. This operation was the first operation during the hospitalization.
4. Consent to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with a history of alcohol or drug addiction.
2. Patients with disturbance of consciousness before operation.
3. Other conditions considered by the attending physician or researcher to be inappropriate for the study;
4. History of chronic pain.
5. Abnormal coagulation function.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echogenic nerve block needle; Using a echogenic nerve block needle.	Procedure: Echogenic nerve block needle; A 22G 8-cm echogenic nerve block needle (LEAPMED, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The spread of the medication will be assessed through short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the incidence of punctures, and any associated complications are all meticulously appraised.
Other: Non-echogenic nerve block needle; Using a common nerve block needle.	Procedure: Non-echogenic nerve block needle; A 22G 8-cm thin wall low bottom nerve block needle (KDL, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The distribution of the medication will be assessed using short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the number of punctures, and any associated complications are all meticulously appraised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic postoperative pain	Incidence of Chronic pain assessment from 3 months after surgery	The third month after surgery.
Moderate to severe pain	Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4	from end of surgery to 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute postoperative pain	Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4	From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Acute postoperative pain	Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4	From return to the ward to 12 hours after return to the ward
Acute postoperative pain	Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4	From 12 hours after return to the ward to 24 hours after return to the ward
Puncture operation time	Time from needle insertion to needle extraction	From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Number of needle passes	The number of times the needle is withdrawn more than 2 cm and resited	From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Chair: He Huang, ph.D, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic pain; Acute pain; Visualized nerve block needle
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CPSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Within one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No