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NCT Number: NCT06281431

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

He Huang

Chongqing, Chongqing Municipality, 4000000, China

Location status: Recruiting

Location contact

He Huang, ph.D

CONTACT

[email protected]

13708385559

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Echogenic nerve block needle

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

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.

Primary outcomes

  1. Chronic postoperative pain

    Time frame: The third month after surgery.

    Incidence of Chronic pain assessment from 3 months after surgery

  2. Moderate to severe pain

    Time frame: from end of surgery to 24 hours after surgery.

    Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4

Secondary outcomes

  1. Acute postoperative pain

    Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes

    Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4

  2. Acute postoperative pain

    Time frame: From return to the ward to 12 hours after return to the ward

    Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4

  3. Acute postoperative pain

    Time frame: From 12 hours after return to the ward to 24 hours after return to the ward

    Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4

  4. Puncture operation time

    Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes

    Time from needle insertion to needle extraction

  5. Number of needle passes

    Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes

    The number of times the needle is withdrawn more than 2 cm and resited

Study contacts

Contact information is provided by the study sponsor or research team.

Da gang Wang, ph.D

CONTACT

[email protected]

023 63693014

He Huang, ph.D

CONTACT

[email protected]

13708385559

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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