Back to resultsEffects of Regional Nerve Block on Cancer Recurrence
Primary Purpose
Cancer Patient
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Normal saline
peripheral Nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Patient focused on measuring Regional nerve block, cancer recurrence
Eligibility Criteria
Inclusion Criteria:
- Patients with primary cancer undergoing elective surgery under general anesthesia
Exclusion Criteria:
- 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.
Sites / Locations
- The first affiliated hospital of nanchang university
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Normal saline
peripheral Nerve block
Arm Description
equal volume of normal saline as treatment group
0.35% ropivacaine and 0.5% lidocaine in normal saline
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
dosage of intraoperative anesthetic
Record the propofol and remifentanil during the operation
the effect of nerve block on the percentage and classification of immunocyte and content of cytokines
percentage and classification of immunocyte will be detected by Use flow cytometry, and cytokines will be detected by ELISA
VAS after operation
Assess the visual analogue scale 24，48h after nerve block
activity after operation
Observe recovery time of gastrointestinal function and off-bed activity after nerve block
Hospital stay
Observe length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03134430
Brief Title
Effects of Regional Nerve Block on Cancer Recurrence
Official Title
Effects of Regional Nerve Block on Cancer Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
March 25, 2018 (Actual)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luo Foquan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
To study the effects of TAP block under ultrasound guide on the recurrence of gastric carcinoma, colon cancer, rectal carcinoma and liver cancer and the underlying mechanisms.
To clarify the effects of Lateral thoracic nerve block under ultrasound guide on the recurrence of lung cancer and the underlying mechanisms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patient
Keywords
Regional nerve block, cancer recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
equal volume of normal saline as treatment group
Arm Title
peripheral Nerve block
Arm Type
Active Comparator
Arm Description
0.35% ropivacaine and 0.5% lidocaine in normal saline
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Injection of Normal saline around peripheral nerve
Intervention Type
Other
Intervention Name(s)
peripheral Nerve block
Intervention Description
Injection of local anesthetics around peripheral nerve
Primary Outcome Measure Information:
Title
the effect of nerve block on the cancer recurrence rate and survival rate postoperation
Description
to trace cancer recurrence after tumor resection with CT scaning and tumor biological maker test for 5 years
Time Frame
up to 5 years after surgery
Secondary Outcome Measure Information:
Title
dosage of intraoperative anesthetic
Description
Record the propofol and remifentanil during the operation
Time Frame
intraoperative period
Title
the effect of nerve block on the percentage and classification of immunocyte and content of cytokines
Description
percentage and classification of immunocyte will be detected by Use flow cytometry, and cytokines will be detected by ELISA
Time Frame
at 0h, 24h, 48h after nerve block
Title
VAS after operation
Description
Assess the visual analogue scale 24，48h after nerve block
Time Frame
at 24h, 48h after nerve block
Title
activity after operation
Description
Observe recovery time of gastrointestinal function and off-bed activity after nerve block
Time Frame
up to 2 weeks
Title
Hospital stay
Description
Observe length of hospital stay
Time Frame
up to 4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with primary cancer undergoing elective surgery under general anesthesia
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Foquan Luo, professor
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of nanchang university
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Regional Nerve Block on Cancer Recurrence
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