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

NCT05360173 | Unknown

• 1 other identifier: DMR-111-166
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain

Keywords

Laparoscopic surgery; post-operative pain; acupressure; analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Times of exhaust air

  3 days

• recovery of bowel movement

  3 days

• Timing of first flatus

  3 days

• postoperative length of stay

  Postoperative day to discharge (about 5-7 days)

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

The control group will have the same treatment and the evaluation, except received sham acupoint.

Behavioral: sham acupressure

Interventions

acupressure BEHAVIORAL

The researcher use thumb and put about 3 kilogram on four acupoints where locating on the patient's arm and leg.

Experimental group

sham acupressure BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Supervisor

Model Details: 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 Record Dates

• First Submitted: April 21, 2022
• First Posted: May 4, 2022
• Study Start: June 16, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05