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New pain shot could ease recovery after hemorrhoid surgery

NCT ID NCT02468128

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single injection of a long-acting painkiller called SDE in 221 adults recovering from hemorrhoid surgery. Half received the drug and half a placebo. Researchers measured pain levels and how much extra pain medicine was needed over 48 hours. The goal was to see if SDE provides better pain control after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sebacoyl dinalbuphine ester (SDE), a long-acting painkiller injection
What this could lead to
If it works, this could provide a single-injection option for managing pain after hemorrhoid surgery, reducing the need for other pain medications.
What could go wrong
This is a completed Phase 2/3 trial, but results may not apply to other types of surgery or pain. The drug may cause side effects like nausea or dizziness, and it may not work better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

221 people

The number who actually took part.

Start date

Dec 2012

Finished

Apr 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female \>= 20 years of age at Screening * Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy * American Society of Anesthesiology Physical Class 1 - 3 * Adequate clinical lab values (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator. * Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires Exclusion Criteria: * Body weight less than 40 kg. * Concurrent fissurectomy. * Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline. * Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study. * History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study. * Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg. * Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery. * Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit. * Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery. * Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period. * Contraindication to epinephrine or any of the pain-control agents planned for postoperative use. * Administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration. * Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance. * Significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial. * Any clinically significant event or condition may be uncovered during surgery. * History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years. * Known history of anti-HIV antibody positive * Failure to pass drug and alcohol screen.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chang Gung Memorial Hospital at Chiayi

    Chiayi City, Chiayi Hsien, 61363, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung City, 88301, Taiwan

  • Chang Gung Memorial Hospital at Keelung

    Keelung, 20401, Taiwan

  • Chang Gung Memorial Hospital at Linkou

    Linkou District, New Taipei City, 244, Taiwan

  • Cheng Ching General Hospital

    Taichung, 40764, Taiwan

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

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