The Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function After Laparoscopic Surgery

Explore the Effectiveness of Acupressure on Reducing Pain and Improving Gastrointestinal Function of Patients After Laparoscopic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Behavioral: acupressure; Behavioral: sham acupressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The experimental group not only have the routine treatment, but have acupressure when they back to the ward with the following 3 days . The effectiveness evaluation was carried out by the same researcher before and after intervention. There are three assessments in this study: primary outcome including postoperative pain and bowel movement. The short-form McGill Pain Questionnaire is used to measure the quality of pain, Visual Analog Scale is used to the pain intensity and stethoscope is used to listen to the bowel sound. The study, also, will be recorded postoperative exhaust time, the postoperative date of Indwelling drainage tube and postoperative length of stay.	Behavioral: acupressure; The researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg.
Sham Comparator: Control group; The control group will have the same treatment and the evaluation, except received sham acupoint.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Timing of first flatus	asking the patient the timing of the first flatus after surgery, time is the shorter the better	3 days
postoperative length of stay	recording from the chart, time is the shorter the better	Postoperative day to discharge (about 5-7 days)

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 16, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; analgesia; post-operative pain; acupressure
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: DMR-111-166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No