Effects of Regional Nerve Block on Cancer Recurrence

NCT03134430 | Unknown

• 1 other identifier: LFoquan
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

It has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and invasion ability，but it is still lack of clinical evidence. Our study aims to explore the effects of regional nerve block on cancer recurrence and the mechanism.

Conditions

Cancer Patient

Keywords

Regional nerve block; cancer recurrence

Outcome Measures

Primary Outcomes (1)

• the effect of nerve block on the cancer recurrence rate and survival rate postoperation

  to trace cancer recurrence after tumor resection with CT scaning and tumor biological maker test for 5 years

  up to 5 years after surgery

Secondary Outcomes (5)

• dosage of intraoperative anesthetic

  intraoperative period

• the effect of nerve block on the percentage and classification of immunocyte and content of cytokines

  at 0h, 24h, 48h after nerve block

• VAS after operation

  at 24h, 48h after nerve block

• activity after operation

  up to 2 weeks

• Hospital stay

  up to 4 weeks after surgery

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

equal volume of normal saline as treatment group

Other: Normal saline

peripheral Nerve block

ACTIVE COMPARATOR

0.35% ropivacaine and 0.5% lidocaine in normal saline

Other: peripheral Nerve block

Interventions

Normal saline OTHER

Injection of Normal saline around peripheral nerve

Normal saline

peripheral Nerve block OTHER

Injection of local anesthetics around peripheral nerve

peripheral Nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary cancer undergoing elective surgery under general anesthesia

You may not qualify if:

• Disagree to participate，drop out,lose track, infectious abdominal wall，abnormal puncture point，coagulation dysfunction，allergy of local anesthetic ，immune disease,cancer metastasis,mental disease, acute and chronic infectious disease or other severe disease.

Sponsors & Collaborators

• Luo Foquan: lead

Study Sites (1)

The first affiliated hospital of nanchang university

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Foquan Luo, professor

  The First Affiliated Hospital of Nanchang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: the patients in treatment group will received reginoal nerve block with 0.35% Ropivacane and 0.5% lidocaine in normal saline under ultrasound guide, while those in control group received equal volume of normal saline.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: May 1, 2017
• Study Start: July 10, 2017
• Primary Completion: March 25, 2018
• Study Completion: May 1, 2023
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

CN (1)