Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a Randomized Controlled Trial

NCT04111081 | Unknown

• 1 other identifier: CXTD1701
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.

Conditions

Postoperative Pain

Keywords

hemorrhoidectiomy; postoperative pain; auricular pressure

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale(VAS)

  It is a unidimensional measure providing a simple solution for measuring subjective experience. The VAS scale is a 10-cm line with 0 cm indicating no symptoms and 10 cm indicates the greatest extent of symptoms. Twenty-four hours after the operation, VAS\>3 in the case of an analgesic pump can be included in the randomized control group.

  Day 1 after randomization.

Secondary Outcomes (3)

• Hospital Anxiety and Depression scale(HAD)

  Twenty-four hours, three days, and seven days after surgery

• The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)

  Day 7 after randomization.

• Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)

  Day 7 after randomization.

Other Outcomes (1)

• Tissue edema

  Day 3, day4, day5, day6 and day7 after randomization.

Study Arms (2)

Auricular pressure

EXPERIMENTAL

Use wangbuliuxing seed to stimulate auricular acupuncture point.

Other: Auricular pressure

Sham auricular pressure

SHAM COMPARATOR

Use wangbuliuxing seed to stimulate auricular acupuncture point.

Other: Shame auricular pressure

Interventions

Auricular pressure OTHER

Select related auricular points: Shenmen(TF4), sympathetic(AH6a), rectum(HX2), anus(HX5), stomach(CO4), subcortical(AT4). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.

Auricular pressure

Shame auricular pressure OTHER

Select unrelated auricular points: eye(LO5), occipital(AT3), tonsil(LO7,8,9), lower auricular root(R3), dorsum auricular kidney(P5) and dorsum auricular lung(P2). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.

Sham auricular pressure

Eligibility Criteria

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

You may qualify if:

• Meet the diagnostic criteria of grade II-IV mixed hemorrhoids and meet the operation conditions;
• Age 18\~65;
• External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia;
• VAS score ≥3 points after the implementation of analgesia pump;
• Improve clinical auxiliary examination and sign informed consent.

You may not qualify if:

• Combined with inflammatory hemorrhoids, thrombotic hemorrhoids, perianal eczema, perianal abscess and other perianal diseases that affect the evaluation of curative effect;
• Combined with intestinal infectious diseases, intestinal polyps, rectal malignant tumors, etc;
• Combined with severe cardiovascular disease, immune deficiency, mental disorder, or severe liver and kidney dysfunction;
• Auricle skin lesions or auricle skin allergy to tape is difficult to tolerate treatment;
• Combined cognitive impairment could not complete the efficacy; evaluation;
• Pregnancy or planned pregnancy.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hui Zheng, PhD

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: October 1, 2019
• Study Start: March 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

CN (1)