Phase 2 Herniorrhaphy Study for Opioid Elimination (NCT03695367) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Herniorrhaphy Study for Opioid Elimination
United States63 participantsStarted 2018-10-01
Plain-language summary
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Exclusion Criteria:
* Had any prior inguinal hernia repair except as a child (less than 6 years of age).
* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
* Has taken long-acting opioids within 3 days prior to the scheduled surgery.
* Has taken any opioids within 24 hours prior to the scheduled surgery.
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
* Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pa…