New pain shot could ease recovery after hemorrhoid surgery
NCT ID NCT02468128
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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221 people
The number who actually took part.
- Start date
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Dec 2012
- Finished
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Apr 2015
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Chang Gung Memorial Hospital at Chiayi
Chiayi City, Chiayi Hsien, 61363, Taiwan
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Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 88301, Taiwan
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Chang Gung Memorial Hospital at Keelung
Keelung, 20401, Taiwan
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Chang Gung Memorial Hospital at Linkou
Linkou District, New Taipei City, 244, Taiwan
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Cheng Ching General Hospital
Taichung, 40764, Taiwan
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Tri-Service General Hospital
Taipei, 114, Taiwan
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