Inclusion criteria |
Men and women age between 18 and 70, inclusive
Pain intensity (NRS) ≥4 at initial postoperative measurement in PACU
Participants undergoing planned laparoscopic colorectal surgery
Ability to provide written informed consent
Ability to understand study procedures and communicate clearly with the investigator and staff
ASA risk class of I–III
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Exclusion criteria Surgical factors |
Emergency or unplanned surgery
Repeat operation (eg, previous surgery within 30 days for same condition)
Cancer-related condition causing preoperative pain in site of surgery
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Exclusion criteria Participant criteria |
Women with childbearing potential (women age 18–55 must undergo pregnancy test)
Women who are pregnant or breast feeding
Chronic pain diagnosis (eg, ongoing pain at baseline with NRS≥4/10)
Unstable or poorly controlled psychiatric condition (eg, untreated PTSD, anxiety or depression). Participants who take stable doses (same dose >30 days) of antidepressants and antianxiety drugs may be included.
Unstable or acute medical condition (eg, unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS)
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Exclusion criteria Pharmacologic considerations |
Renal or hepatic impairment
History of alcohol, opiate or other drug abuse or dependence within 12 months prior to screening (TICS alcohol/drug screen will be performed at screening)
Ongoing or recent (within 30 days prior to surgery) use of steroids, opioids or antipsychotics
Alcohol consumption within 24 hours of surgery
Use of NSAIDs or acetaminophen within 24 hours of surgery
Use of herbal agents or nutraceuticals (ie, chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St John's wort, or valerian) within 7 days prior to surgery
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Exclusion criteria Anaesthetic considerations |
Use of neuraxial or regional anaesthesia related to the surgery
Use of local anaesthetic wound infiltration >20 mL of 1% lidocaine
Use of ketamine, gabapentin, pregabalin or lidocaine (>1 mg/kg) intraoperatively or perioperatively, or within 24 hours of surgery
Participants with known allergies to hydromorphone
Participants who received another investigational drug within 30 days of scheduled surgery
Participants who have long PR (>200 ms) or prolonged QTc (>450 ms for males and >470 ms for females) at screening or clinically significant prolonged QTc (>500 ms or change in baseline of >60 ms) on an ECG performed immediately prior to dosing
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