Cancer PatientNCT03134430
Effects of Regional Nerve Block on Cancer Recurrence
A study testing Normal saline and peripheral Nerve block in people with Cancer Patient, run by Luo Foquan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Patient
- What is being tested?
- Normal saline and peripheral Nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with primary cancer undergoing elective surgery under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of nanchang university
Nanchang, Jiangxi, 330006
About this study
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.
Read the 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.
- Conditions
- Cancer Patient
- Being tested
- Normal saline, peripheral Nerve block
- Keywords
- Regional nerve block, cancer recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
Injection of Normal saline around peripheral nerve
peripheral Nerve blockOther
Injection of local anesthetics around peripheral nerve
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | equal volume of normal saline as treatment group Receives: Other: Normal saline |
| peripheral Nerve block | Active comparator | 0.35% ropivacaine and 0.5% lidocaine in normal saline Receives: Other: peripheral Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 5 years after surgery
Secondary outcomes (5)
dosage of intraoperative anesthetic
Record the propofol and remifentanil during the operation
Measured: intraoperative period
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
Measured: at 0h, 24h, 48h after nerve block
VAS after operation
Assess the visual analogue scale 24，48h after nerve block
Measured: at 24h, 48h after nerve block
activity after operation
Observe recovery time of gastrointestinal function and off-bed activity after nerve block
Measured: up to 2 weeks
Hospital stay
Observe length of hospital stay
Measured: up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start10 Jul 2017
- Primary completion25 Mar 2018
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luo Foquan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luo Foquan, The First Affiliated Hospital of Nanchang University
- Investigators
- Foquan Luo, professor, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134430
- Sponsor's protocol ID
- LFoquan
- Status last verified
- May 2018
- First submitted
- 20 Mar 2017
- Last updated
- 25 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regional Nerve Block on Cancer Recurrence
- ClinicalTrials.gov ID
- NCT03134430
- Acronym / sponsor ID
- LFoquan
- Conditions
- Cancer Patient
- Keywords
- Regional nerve block, cancer recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Luo FoquanUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 25 Mar 2018 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Other: Normal salineequal volume of normal saline as treatment group |
| peripheral Nerve block | Active comparator | Other: peripheral Nerve block0.35% ropivacaine and 0.5% lidocaine in normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary cancer undergoing elective surgery under general anesthesia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineInjection of Normal saline around peripheral nerve | Other | Normal saline |
| peripheral Nerve blockInjection of local anesthetics around peripheral nerve | Other | peripheral Nerve block |
Primary outcome
the effect of nerve block on the cancer recurrence rate and survival rate postoperation
Time frame: up to 5 years after surgery
to trace cancer recurrence after tumor resection with CT scaning and tumor biological maker test for 5 years
5 secondary outcomes
dosage of intraoperative anesthetic
Time frame: intraoperative period
the effect of nerve block on the percentage and classification of immunocyte and content of cytokines
Time frame: at 0h, 24h, 48h after nerve block
VAS after operation
Time frame: at 24h, 48h after nerve block
activity after operation
Time frame: up to 2 weeks
Hospital stay
Time frame: up to 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Foquan Luo, professor study chair
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and peripheral Nerve block in people with Cancer Patient, run by Luo Foquan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of nerve block on the cancer recurrence rate and survival rate postoperation (time frame: up to 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.