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

NCT ID: NCT06281431

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Echogenic nerve block needle

Using a echogenic nerve block needle.

Group Type EXPERIMENTAL

Echogenic nerve block needle

Intervention Type PROCEDURE

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

Using a common nerve block needle.

Group Type OTHER

Non-echogenic nerve block needle

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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He Huang, ph.D

Role: STUDY_CHAIR

The Second Affiliated Hospital, Chongqing Medical University

Locations

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He Huang

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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He Huang, ph.D

Role: CONTACT

13708385559

Da gang Wang, ph.D

Role: CONTACT

023 63693014

Facility Contacts

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He Huang, ph.D

Role: primary

13708385559

Other Identifiers

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CPSP

Identifier Type: -

Identifier Source: org_study_id

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