HTX-011 in Spinal Surgery

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter study in subjects undergoing an open 2-level, lumbar laminectomy without fusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heron Therapeutics
• Treatments: Bupivacaine; Epinephrine

Criteria

Inclusion Criteria:

• Is scheduled to undergo an open 2-level lumbar laminectomy without fusion under general anesthesia..

• Has not previously undergone multilevel laminectomy or fusion.

• Can ambulate at least 20 meters with optional use of an assisted device for balance.

• Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives.

Exclusion Criteria:

• Has a planned concurrent surgical procedure.

• Has a contraindication or a known or suspected history of hypersensitivity to required study medications.

• Has a pre-existing concurrent painful physical/restrictive condition expected to require analgesic treatment in the postoperative period.

• Has a history of an intrathecal drug pump or spinal cord stimulator.

• Has a known or suspected daily use of opioids for a period of at least 30 days in the previous 6 months.

• Has taken meloxicam or any other NSAID within 10 days prior to the scheduled surgery.

• Has been administered bupivacaine within 5 days or any local anesthetic within 72 hours prior to the scheduled surgery.

• Has taken selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin to control pain within 1 month prior to the scheduled surgery.

• Has been administered systemic steroids within 10 days prior to the scheduled surgery.

• Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.

• Has a known or suspected history of drug abuse or alcohol abuse (within 10 years).

• Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.

• Has loss of sensation in lower extremities or peripheral neuropathy that interferes with balance or walking.

• Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.

• Has uncontrolled anxiety, psychiatric, or neurological disorder.

• Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

• Has undergone 3 or more surgeries within 12 months.

• Has a known history of glucose-6-phosphate dehydrogenase deficiency.