Gastrointestinal Carcinoma, Pain
Conditions
Keywords
Acupuncture Therapy, Pain degree after surgery
Brief summary
Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.
Interventions
DEVICEAcupuncture therapy
PROCEDURELaparoscopic Surgery
Sponsors
Xiaonan Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic; 2. Pathology diagnosed; 3. Brain, heart, lung, liver, kidney are at good condition before surgery; 4. No mental disorder, no conscious obstacle, no limbs disability.
Exclusion criteria
1. Severely complication after surgery; 2. Contraindication of the acupuncture; 3. Patients with mental disease; 4. Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS) | day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Prostaglandin E2(PGE2) in blood | day 2,day 7 after surgery |
| Estradiol(Female) in blood | day 2, day 7 after surgery |
| Th1/Th2 in blood | day 2, day 7 after surgery |
| Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability | day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery |
| Histamine(HIS) in blood | day 2,day 7 after surgery |
| Th17/Treg in blood | day 2, day 7 after surgery |
| Testosterone(Male) in blood | day 2,day 7 after surgery |
| 5-Hydroxytryptamine(5-HT) in blood | day 2,day 7 after surgery |
Outcome results
None listed