Todd Bertoch
Salt Lake City, Utah, 84101, United States
NCT Number: NCT05813847
Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Salt Lake City, Utah, 84101, United States
Subjects pain and rescue medication use is assessed after having received either CPL-01, placebo, or ropivacaine HCl for several days after hernia repair surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Local infiltration of study drug
Other names: CPL-01
Opioid rescue allowed by IV if requested
Other names: Opioid (Intravenous [IV] morphine) rescue medication
Acetaminophen rescue allowed if requested
Other names: Non-opioid (oral [PO] acetaminophen) rescue medication
Opioid rescue allowed by mouth if requested
Other names: Opioid (oral [PO] oxycodone) rescue medication
Local infiltration of study drug
Other names: Normal Saline
Local infiltration of study drug
Other names: Naropin
Surgical hernia repair
Other names: Herniorrhaphy
Time frame: 72 hours
Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable
Cali Pharmaceuticals LLC
Industry
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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