New pill could ease pain after hemorrhoid surgery
NCT ID NCT02193620
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tested an oral soft capsule of nalbuphine, a painkiller, for people recovering from hemorrhoid surgery. 106 adults took either the drug or a placebo for up to 2 days. Researchers measured pain levels and how much extra pain relief was needed. The goal was to see if the oral capsule is safe and effective for post-surgery pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nalbuphine (oral soft capsule)
- What this could lead to
- If it works, this could provide a new oral option for managing pain after hemorrhoid surgery, reducing the need for injections.
- What could go wrong
- This is a small, early-phase trial (Phase 2/3) with only 106 participants. The results may not apply to everyone, and the drug may not be more effective than existing painkillers.
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
-
106 people
The number who actually took part.
- Started
-
Apr 2013
- Finished
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Feb 2019
- 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 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: 1. Male or female \>= 20 years of age at Screening 2. Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy 3. American Society of Anesthesiology Physical Class 1 - 3 4. Clinical lab values twice the upper limit of normal (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator. 5. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires. Exclusion Criteria: 1. Body weight less than 40 kg. 2. Concurrent fissurectomy. 3. Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline. 4. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, Intrauterine Device (IUD), barrier device or abstinence) throughout the study. 5. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study. 6. Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg. 7. Use of any NSAIDs, selective Cyclooxygenase-2 Inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery. 8. 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. 9. Use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery. 10. Current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period. 11. Contraindication to epinephrine or any of the pain-control agents planned for postoperative use. 12. 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. 13. Any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance. 14. 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. 15. Any clinically significant event or condition uncovered during surgery. 16. History of abuse illicit drugs, prescription medicines or alcohol within the past 2 years. 17. Known history of anti-HIV antibody positive . 18. 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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General Clinical Research Center, Tri-service General Hospital
Taipei, 114, Taiwan
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