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

NCT06281431 | Recruiting DMC

• 1 other identifier: CPSP
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Postoperative Pain

Keywords

Visualized nerve block needle; Acute pain; Chronic pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Acute postoperative pain

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

• Acute postoperative pain

  From return to the ward to 12 hours after return to the ward

• Acute postoperative pain

  From 12 hours after return to the ward to 24 hours after return to the ward

• Puncture operation time

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

• Number of needle passes

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

Study Arms (2)

Echogenic nerve block needle

EXPERIMENTAL

Using a echogenic nerve block needle.

Procedure: Echogenic nerve block needle

Non-echogenic nerve block needle

OTHER

Using a common nerve block needle.

Procedure: Non-echogenic nerve block needle

Interventions

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.

Echogenic nerve block needle

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.

Non-echogenic nerve block needle

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

He Huang

Chongqing, Chongqing Municipality, 4000000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• He Huang, ph.D

  The Second Affiliated Hospital, Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

He Huang, ph.D

CONTACT

13708385559; huanghe@cqmu.edu.cn

Da gang Wang, ph.D

CONTACT

023 63693014; kuanrenlunli@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 28, 2024
• Study Start: June 12, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year

Locations

CN (1)