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Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Phase 4 trial testing EXPAREL and Bupivacaine in Postoperative Pain Management in 65 participants. Terminated before completion.
| Lead sponsor | Pacira Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 31 July 2019 |
| Primary completion | 4 August 2020 |
| Estimated completion | 4 August 2020 |
| Sites | 12 locations across United States |
Pacira Pharmaceuticals, Inc — full company profile →
Adults 18 to 75, any sex, with Postoperative Pain Management. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 Control Group | 90.7 | ± 96.91 |
| Cohort 2 Control Group | 56.8 | ± 5.30 |
| Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) | 51.6 | ± 60.98 |
| Cohort 3 Control Group | 83.6 | ± 109.84 |
Post-surgical opioid consumption in mg MED PO at 14 days after surgery
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 Control Group | 279 | ± 330.66 |
| Cohort 2 Control Group | 330.8 | ± 42.78 |
| Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) | 158.4 | ± 242.71 |
| Cohort 3 Control Group | 187.7 | ± 252.40 |
Time to first opioid rescue through 72 hours or discharge.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 Control Group | 0.82 | 0.58 – 8.02 |
| Cohort 2 Control Group | 0.36 | 0.03 – 0.68 |
| Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) | 3.07 | 0.60 – 25.10 |
| Cohort 3 Control Group | 0.95 | 0.83 – 1.52 |
Time frame: AEs were collected from time of signing informed consent to Day 30 phone call.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1:Open or Mini-open… | Cohort 1 Control Group | Cohort 2: Tubular or Percu… | Cohort 2 Control Group | Cohort 3: Lumbar Decompres… | Cohort 3 Control Group |
|---|---|---|---|---|---|---|---|
| Cauda equina syndrome | Nervous system disorders | — | — | — | — | — | — |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Spinal epidural haematoma | Nervous system disorders | — | — | — | — | — | — |
| Reaction | System | Cohort 1:Open or Mini-open… | Cohort 1 Control Group | Cohort 2: Tubular or Percu… | Cohort 2 Control Group | Cohort 3: Lumbar Decompres… | Cohort 3 Control Group |
|---|---|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Disturbance in attention | Nervous system disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Dysuria | Renal and urinary disorders | — | — | — | — | — | — |
| Radiculopathy | Nervous system disorders | — | — | — | — | — | — |
| Stitch abcess | Infections and infestations | — | — | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Peripheral swelling | General disorders | — | — | — | — | — | — |
| Extradural Hematoma | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Postoperative wound complication | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — | — | — |
| Purulent discharge | Infections and infestations | — | — | — | — | — | — |
| Tooth infection | Infections and infestations | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Blood pressure decreased | Investigations | — | — | — | — | — | — |
Most-reported serious reactions: Cauda equina syndrome, Lumbar Spinal Stenosis, Spinal epidural haematoma.
Data from ClinicalTrials.gov NCT03927911 adverse events section.
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine surgeries where both groups are receiving a multimodal pain regimen. Secondary Objectives: The secondary objectives of this study are to: 1. Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries through 72 hours, including time to first opioid and opioid-related adverse events (ORAEs). 2. Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including discharge readiness, hospital (or other facility) length of stay (LOS), discharge disposition, hospital readmissions, and health service utilization.
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