Table 1

Inclusion and exclusion criteria for phase II VVZ-149 study

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

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

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)

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

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

  • ASA, American Society of Anesthesiologists; NRS, Numerical Pain Rating Scale; NSAID, non-steroidal anti-inflammatory drug; PACU, postoperative anaesthesia care unit; PTSD, post-traumatic stress disorder, TICS, two-item conjoint screen.