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

Chronic Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06281431
• Other study ID #: CPSP
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: He Huang, ph.D
• Phone: 13708385559
• Email: huanghe[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	He Huang	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic postoperative pain	Incidence of Chronic pain assessment from 3 months after surgery	The third month after surgery.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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