Patients will be randomly divided into treatment group (acupuncture plus Tramadol) and control group (sham acupuncture plus Tramadol) with a random number table in 1:1 ratio.
Age
35-75
Control
Sham
sham acupuncture plus Tramadol(n=36)
Experiment
acupuncture plus Tramadol(n=36)
Indicator
Numeric rating scale(NRS)Karnofsky performance scoreBrief pain inventoryBlood routineLiver and kidney function
Auxiliary Medication
Tramadol Hydrochloride Sustained Release Tablets (Shandong Xinhua Pharmaceutical Company Limited, H19990062), 100 mg, and twice a day for 14 days.
Stimulation Method
MS
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
-
-
70-90 times/min
-
moderate percussion
10 min
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
plum blossom needles
Gushi Medical Instrument Co., LTD, 20192200580
-
Description 70 to 90 times per minute for 10 minutes, with moderate percussion intensity
Anesthesia Method
GA
Clinical Trial Type
random
Contraindications
With contraindication plum-blossom needles, such as wounds, ulcers, scars at the puncture site
Effector
The results will help to evaluate the efficacy and safety of plum-blossom needle acupuncture in improving CPSP after lobectomy in NSCLC patients.
Acupuncture against chronic postsurgical pain in non-small cell lung cancer patients: A protocol of randomized controlled trial.
Abstract
INTRODUCTION: Video-assisted thoracoscopic lobectomy is the prior recommended treatment for non-small cell lung cancer (NSCLC), with the advantages of small trauma, less postoperative pain, and quick recovery. However, a large number of patients may suffer chronic postsurgical pain (CPSP), which makes the patients unwilling to practice pulmonary exercises, and it would directly affect patient's cough, sputum expectoration, and mobility. Opioids could greatly improve the quality of postoperative analgesia and the quality of life after surgery, but it is accompanied with obvious side effects. A number of clinical studies have proved that acupuncture could improve postoperative pain and reduce opioid use. In this study, we try to conduct a randomized controlled study to evaluate the efficacy and safety of plum-blossom needle acupuncture combined with Tramadol in improving CPSP after lobectomy in NSCLC patients. METHODS: Patients will be randomly divided into treatment group (acupuncture plus Tramadol) and control group (sham acupuncture plus Tramadol) with a random number table in 1:1 ratio. The patients, outcome assessor, and statistician will be blinded. The outcomes are changes of numerical rating scale, Karnofsky performance score, brief pain inventory, blood routine, liver and kidney function. The data will be analyzed by SPSS 22.0. CONCLUSIONS: The results will help to evaluate the efficacy and safety of plum-blossom needle acupuncture in improving CPSP after lobectomy in NSCLC patients."
Souce
Medicine (Baltimore). 2021 Oct 8;100(40):e27461. doi: 10.1097/MD.0000000000027461.
