Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery

NCT04217213 | Unknown

• 1 other identifier: XYFY2019-KL169-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic pain after chest surgery

  The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".

  At the 3rd month after surgery

Secondary Outcomes (9)

• The incidence of acute pain after chest surgery

  24 to 72 hours after surgery

• Incidence of postoperative neuropathic pain

  At the 3rd month after surgery

• Incidence of other postoperative complications

  At the 3rd month after surgery

• Incidence of readmission within 30 days after surgery

  At the 30 days after surgery

• Incidence of death within 30 days after surgery

  At the 30 days after surgery

Study Arms (2)

ropivacaine combined with mecobalamine

EXPERIMENTAL

Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).

Procedure: Intercostal nerve block

ropivacaine

ACTIVE COMPARATOR

Intercostal nerve block with 0.5% ropivacaine alone.

Procedure: Intercostal nerve block

Interventions

Intercostal nerve block PROCEDURE

In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

ropivacaine; ropivacaine combined with mecobalamine

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, conscious;
• ASA class Ⅰ \~ Ⅲ;
• Thoracoscopic lobectomy was proposed;
• The han nationality;
• Native speaker of Chinese;
• Agree to participate in this study and sign the informed consent.

You may not qualify if:

• Patients allergic to meccobalamin or ropivacaine;
• Patients with previous history of chest surgery;
• Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
• Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
• Diabetic patients;
• Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

CN (1)