Pilot Herniorrhaphy Study for Postoperative Analgesia (NCT02504580) | Clinical Trial Compass
CompletedPhase 2
Pilot Herniorrhaphy Study for Postoperative Analgesia
United States463 participantsStarted 2015-07
Plain-language summary
A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be male or female 18 years of age or older.
. Female subjects are eligible only if all of the following apply:
. Plan to undergo a unilateral inguinal herniorrhaphy
. Have the ability and be willing to comply with the study procedures
. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form.
Exclusion criteria
. Unwilling to sign informed consent or not willing or able to complete all study procedures
. Have a contraindication or be allergic to any medication to be used during the trial period
. Have clinically significant cardiac abnormalities, that in the opinion of the investigator would pose a health risk to the subject should they participate in the trial
. Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)
. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT \> 3x ULN, creatinine \> 2x ULN)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have another painful condition that may confound pain assessments
. Have another surgery planned within 30 days of procedure, or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with large scrotal component that would be difficult to reduce surgically
. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen