Effects of Regional Nerve Block on Cancer Recurrence

• Sponsor: Luo Foquan (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03134430
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 69.7
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Patient	Other: Normal saline; Other: peripheral Nerve block	N/A

Detailed Description

1. 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.

2. To clarify the effects of Lateral thoracic nerve block under ultrasound guide on the recurrence of lung cancer and the underlying mechanisms.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Regional Nerve Block on Cancer Recurrence
• Actual Study Start Date: Jul 10, 2017
• Actual Primary Completion Date: Mar 25, 2018
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal saline equal volume of normal saline as treatment group	Other: Normal saline; Injection of Normal saline around peripheral nerve
Active Comparator: peripheral Nerve block 0.35% ropivacaine and 0.5% lidocaine in normal saline	Other: peripheral Nerve block; Injection of local anesthetics around peripheral nerve

Outcome Measures

Primary Outcome Measures

1. the effect of nerve block on the cancer recurrence rate and survival rate postoperation [up to 5 years after surgery]

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

Secondary Outcome Measures

1. dosage of intraoperative anesthetic [intraoperative period]

   Record the propofol and remifentanil during the operation

2. the effect of nerve block on the percentage and classification of immunocyte and content of cytokines [at 0h, 24h, 48h after nerve block]

   percentage and classification of immunocyte will be detected by Use flow cytometry, and cytokines will be detected by ELISA

3. VAS after operation [at 24h, 48h after nerve block]

   Assess the visual analogue scale 24，48h after nerve block

4. activity after operation [up to 2 weeks]

   Observe recovery time of gastrointestinal function and off-bed activity after nerve block

5. Hospital stay [up to 4 weeks after surgery]

   Observe length of hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of nanchang university	Nanchang	Jiangxi	China	330006

Sponsors and Collaborators

• Luo Foquan

Investigators

• Study Chair: Foquan Luo, professor, The First Affiliated Hospital of Nanchang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luo Foquan, Professor, The First Affiliated Hospital of Nanchang University
• ClinicalTrials.gov Identifier: NCT03134430
• Other Study ID Numbers: LFoquan
• First Posted: May 1, 2017
• Last Update Posted: May 25, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Luo Foquan, Professor, The First Affiliated Hospital of Nanchang University: Regional nerve block; cancer recurrence
• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of May 25, 2018