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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05360173
Other study ID # DMR-111-166
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 16, 2022
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to explore the effect if acupressure reducing pain after laparoscopic surgery. The study is designed as an experimental research with repeat measurement design. The patients who are eligible for laparoscopic for general surgery and colorectal surgery in a medical center in the central part of Taiwan. The intervention of the research starts from the first date of postoperative day and the patient has the postoperative pain. The participant will be randomized into experimental group and control group. These two groups will be given true acupressure and sham acupressure twice daily. The participant will be observation the postoperative pain and postoperative recovery.


Description:

Laparoscopic is increasing in this decade. The surgical trauma caused postoperative pain which cannot be avoid. It is the significant challenge and the thorny issue of the healthcare providers, also, be discussed for many decades. Several clinical researches have been verified acupuncture and related method have been as adjuvant efficacy treatment for decreasing postoperative pain. Acupressure is the method of the thumb put acupoint, and therapeutic effectiveness is similar to acupuncture. Acupressure is allowed to a nurse work independently due to noninvasive treatment. However, the less of the clinical studies explore the efficacy of acupressure reducing the postoperative pain after laparoscopic. The result of the research will provide the efficacy of reducing postoperative laparoscopic pain and wish to improve the quality of care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 86
Est. completion date December 31, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - laparoscopic surgery on the organ of liver, gastric, small intestine, colon under general anaethesia - the American Society of Anesthesiologists (ASA) :I - III - above 20 years old - the state of consciousness is alert - Chinese or Taiwanese speaker Exclusion Criteria: - surgical procedure: resection, low anterior resection, Roux-en-Y Gastric Bypass and Whipple procedure (pancreaticoduodenectomy) - postoperative length of hospital stay less than 3 days - patient have pregnant, maternity, breastfeeding, chronic pain history, coagulation disorder or skin injury on the acupoints. - drug abuse, alcoholism - Patient-controlled analgesia

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
acupressure
The researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg.
sham acupressure
The researcher use thumb and put about 3 kilogram on four acupoints where locating at about 3 cm next to the acupoint on the patient's arm and leg.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain intensity Visual Analog Scale (VAS) of pain is used to measure the pain intensity. The scale of 0 = no pain and 10 = the worst pain, is a 10 cm scale marked in cm. The higher scores means the worse outcome. 3 days
Primary The quality of postoperative pain The short-form McGill Pain Questionnaire (SF-MPQ) is used to measure the quality of pain. The Chinese version is used that consists of 16 descriptors (12 sensory; 4 affective) which rated 0 = none, 1 = mild, 2 = moderate or 3 = severe, and Present Pain Intensity (PPI) and a visual analogue scale (VAS). The higher score means the worse outcome. 3 days
Primary medication consumption The data is recorded from the patient chart about the drugs consumption after surgery. That is included opioid, non-steroidal anti-Inflammatory drugs, prokinetic agent and anti-flatulence drugs. The more medications are used mean the worse outcome. 3 days
Secondary Times of exhaust air The data is recorded by ask the patient whether they have exhaust air or not after intervention. If the patient has exhaust air after the intervention, means the good outcome. 3 days
Secondary recovery of bowel movement The stethoscope is used to listen to the bowel sound, which will be measured by the researcher. The bowel sound increase means the good outcome. 3 days
Secondary Timing of first flatus asking the patient the timing of the first flatus after surgery, time is the shorter the better 3 days
Secondary postoperative length of stay recording from the chart, time is the shorter the better Postoperative day to discharge (about 5-7 days)
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