Cohort Study of Auricular Acupressure for Postoperative Pain After Hemorrhoidectiomy

NCT04111302 | Unknown

• 1 other identifier: CXTD1702
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain After Hemorrhoidectomy

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.

  Day 1 to 7 and month 3 and 6 after natural allocation

Secondary Outcomes (1)

• Hospital Anxiety and Depression scale(HAD)

  Three hours, day 3, and day 7 after natural allocation

Other Outcomes (3)

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

  Day 7 after natural allocation

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

  Day 7 after natural allocation

• Tissue edema

  Day 3,day 4,day 5,day 6 and day 7 after natural allocation

Study Arms (4)

IV-PCA

EXPERIMENTAL

use IV-PCA for postoperative pain

Other: IV-PCA

IV-dezocine

EXPERIMENTAL

use IV-dezocine for postoperative pain

Other: IV-dezocine

IV-PCA+AA

EXPERIMENTAL

use IV-PCA and AA for postoperative pain

Other: IV-PCA+AA

IV-dezocine+AA

EXPERIMENTAL

use IV-dezocine and AA for postoperative pain

Other: IV-dezocine+AA

Interventions

IV-PCA OTHER

IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h.

IV-PCA

IV-dezocine OTHER

IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.

IV-dezocine

IV-PCA+AA OTHER

IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h. And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.

IV-PCA+AA

IV-dezocine+AA OTHER

IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.

IV-dezocine+AA

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;
• Sign informed consent.

You may not qualify if:

• Combined cognitive impairment could not complete the efficacy evaluation;
• With other gastrointestinal conditions found during operation;
• With severe cardiovascular, hepatic, or renal diseases;
• With opioid addiction

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Hui Zheng, phD

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Di Qin, MD

CONTACT

028-87526671; qindi@stu.cdutcm.edu.cn

Wenyan Peng, MD

CONTACT

028-87526671

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• 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: May 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 17, 2020

Record last verified: 2020-02