Postoperative PainNCT04111081
Auricular Pressure for Postoperative Pain After Hemorrhoidectiomy: a Randomized Controlled Trial
A study testing Auricular pressure in people with Postoperative Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Auricular pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
About this study
Official title: Pilot Study of Clinical Randomized Controlled Trial of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.
Read the detailed description
This is a randomized, double-blind study to study the analgesic effect of auricular pressure pill on persistent pain after hemorrhoidectiomy. Baseline pain intensity scores (VAS>3) of the subjects will be collected 24 hours after the operation of the patients. Eligible subjects will be randomly assigned to receive auricular pressure pills or sham-auricular pressure pills. The treatment will last 5-7 days. Participants will receive auricular pressure once two days, and receive VAS, concomitant medication, PONV intensity scale and peripheral edema were recorded daily, and after the operation 24 hours, 3 days and 7 days the patients will receive anxiety and depression scale(HAD) , and VAS data will be collected by telephone at 3 and 6 months after the operation.
The statistical analysis results will be subject to the full analysis set (FAS) results, and a sensitivity analysis will be performed comparing the per-protocol (PP). The main indicators will be analyzed by covariance analysis, with VAS results as the dependent variable, grouping as the random factor, and age, course of disease, surgical method and baseline as the covariables to correct the P value. The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. Whether analgesic will be used as a dependent variable, grouping as a random factor, and age, course of disease, surgical method and evaluation time point will be analyzed as covariables. Other outcome indicators will be analyzed by covariance analysis, and the model will be the same as that of the main indicators. P<0.05 considered as significant difference, and SPSS20.0 used for analysis.
The purpose of this study was to seek high quality evidence-based medical evidence for intervention of auricular pressure pills on postoperative pain of hemorrhoidectomy.
- Conditions
- Postoperative Pain
- Being tested
- Auricular pressure, Shame auricular pressure
- Keywords
- hemorrhoidectiomy, postoperative pain, auricular pressure
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular pressureOther
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.
Shame auricular pressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular pressure | Experimental | Use wangbuliuxing seed to stimulate auricular acupuncture point. Receives: Other: Auricular pressure |
| Sham auricular pressure | Sham comparator | Use wangbuliuxing seed to stimulate auricular acupuncture point. Receives: Other: Shame auricular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 after randomization.
Secondary outcomes (3)
Hospital Anxiety and Depression scale(HAD)
The HAD scale included measures of anxiety and depression, with scores ranging from 0 to 21. 0-7 points means asymptomatic;A score of 8-10 means suspicious;A score of 11 to 21 means definitely symptomatic( anxiety or depression).
Measured: Twenty-four hours, three days, and seven days after surgery
The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)
The ratio of patients using analgesic drugs in each group was calculated (Patients who take bisphenolics once are considered users), and the utilization rate = number of users/total number of users ×100%.
Measured: Day 7 after randomization.
Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)
The total analgesic drugs dose of each group was was considered as the amount of analgesics in the group.
Measured: Day 7 after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Zheng, PhD, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111081
- Sponsor's protocol ID
- CXTD1701
- Status last verified
- Feb 2020
- First submitted
- 17 Sep 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Clinical Randomized Controlled Trial of Auricular Pressure Therapy for Intervention of Postoperative Pain of Hemorrhoidectiomy
- ClinicalTrials.gov ID
- NCT04111081
- Acronym / sponsor ID
- CXTD1701
- Conditions
- Postoperative Pain
- Keywords
- hemorrhoidectiomy, postoperative pain, auricular pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Auricular pressure is effective for postoperative analgesia after hemorrhoidectomy, but the evidence is not sufficient.
Detailed description
This is a randomized, double-blind study to study the analgesic effect of auricular pressure pill on persistent pain after hemorrhoidectiomy. Baseline pain intensity scores (VAS>3) of the subjects will be collected 24 hours after the operation of the patients. Eligible subjects will be randomly assigned to receive auricular pressure pills or sham-auricular pressure pills. The treatment will last 5-7 days. Participants will receive auricular pressure once two days, and receive VAS, concomitant medication, PONV intensity scale and peripheral edema were recorded daily, and after the operation 24 hours, 3 days and 7 days the patients will receive anxiety and depression scale(HAD) , and VAS data will be collected by telephone at 3 and 6 months after the operation.
The statistical analysis results will be subject to the full analysis set (FAS) results, and a sensitivity analysis will be performed comparing the per-protocol (PP). The main indicators will be analyzed by covariance analysis, with VAS results as the dependent variable, grouping as the random factor, and age, course of disease, surgical method and baseline as the covariables to correct the P value. The secondary indicator analgesic usage rate will be analyzed using logistic regression analysis. Whether analgesic will be used as a dependent variable, grouping as a random factor, and age, course of disease, surgical method and evaluation time point will be analyzed as covariables. Other outcome indicators will be analyzed by covariance analysis, and the model will be the same as that of the main indicators. P<0.05 considered as significant difference, and SPSS20.0 used for analysis.
The purpose of this study was to seek high quality evidence-based medical evidence for intervention of auricular pressure pills on postoperative pain of hemorrhoidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular pressure | Experimental | Other: Auricular pressureUse wangbuliuxing seed to stimulate auricular acupuncture point. |
| Sham auricular pressure | Sham comparator | Other: Shame auricular pressureUse wangbuliuxing seed to stimulate auricular acupuncture point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular pressureSelect 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. | Other | Auricular pressure |
| Shame auricular pressureSelect 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. | Other | Sham auricular pressure |
Primary outcome
Visual Analogue Scale(VAS)
Time frame: Day 1 after randomization.
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.
3 secondary outcomes
Hospital Anxiety and Depression scale(HAD)
Time frame: Twenty-four hours, three days, and seven days after surgery
The utilization rate of analgesic drugs(Diclofenac Sodium Dual Release Enteric-coated Capsules)
Time frame: Day 7 after randomization.
Amount of analgesic drugs (Diclofenac Sodium Dual Release Enteric-coated Capsules)
Time frame: Day 7 after randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Zheng, PhD principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular pressure in people with Postoperative Pain, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale(VAS) (time frame: Day 1 after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.