PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopi… (NCT05115955) | Clinical Trial Compass
CompletedPhase 4
PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery
Taiwan76 participantsStarted 2021-11-11
Plain-language summary
Postoperative pain is common, and the pain intensity can be moderate to severe depending on the site of surgery during the first few days after surgery, and an estimated 15% to 45% experience chronic postsurgical pain. When poorly controlled, the pain can have a significant effect on patient recovery. Proper management of postoperative pain is needed to relieve suffering and lead to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The currently proposed clinical use of Dinalbuphine Sebacate is to administer a single dose of NALDEBAIN® intramuscularly approximately 12 to 24 hours prior to the planned surgery for pain relief. Several clinical studies of NALDEBAIN® have been published, such as the use in laparotomy and laparoscopic cholecystectomy. However, toward the arthroscopic shoulder surgery, no article or report has been available publicly yet. The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN® on patients scheduled to undergo arthroscopic shoulder surgery.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Scheduled to undergo arthroscopic shoulder surgery.
âś“. American Society of Anesthesiology Physical Class 1-3.
âś“. Ability and willingness to provide informed consent.
Exclusion criteria
âś•. Not willing to adhere to the study visit schedule.
âś•. With a history of hypersensitivity or allergy to opioids, NSAIDs or sesame oil.
âś•. With a medical history that may predispose them to abnormal intracranial pressure.
âś•. Any history of narcotic dependency, addiction, or withdrawal.
âś•. Any clinically significant condition that may interfere with study assessments.
âś•. Pregnant or breastfeeding.
âś•. Nonregular sinus cardiac rhythm or implanted pacemakers.