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Poster 129 Pain Relief and Its Impact on Sleep in Treatment of Neuropathic Pain Associated with Postherpetic Neuralgia
S134
Abstracts / PM R 7 (2015) S83-S222
PAIN AND SPINE MEDICINE Poster 128 Dosage-Dependent Effectiveness of Treatment of Breakthrough Cancer Pain with Fentanyl Pectin Nasal Spray Jeannine M. Brant, PhD, APRN, AOCN, Iwona Bucior, PhD (Depomed, Inc., Newark, CA, United States), Florin Orza, MD Disclosures: I. Bucior: Employment - Depomed, Inc.; Stock Options or Bond Holdings - Depomed, Inc. Objective: To evaluate the effectiveness, acceptability, and safety of different dosages of Fentanyl Pectin Nasal Spray (FPNS; LazandaÒ) in treatment of breakthrough cancer pain (BTPc). Design: Analysis of data from two randomized Phase 3 studies. Setting: At home with routine clinical visits. Participants: Patients with cancer who were experiencing on average 1-4 episodes of BTPc per day. Interventions: 60 mg/day oral morphine (or equivalent) for background pain, and 100-, 200-, 400-, or 800-mg FPNS or matching placebo for BTPc. Main Outcome Measures: The primary efficacy endpoint was patientaveraged summed pain intensity difference at 30 min post-dose (SPID30). Secondary endpoints included: SPID at 5, 10, 15, 45, and 60 min post-dose; patient acceptability scores (overall satisfaction, speed of relief, reliability, ease of use, and overall convenience of the nasal spray). Results or Clinical Course: Mean baseline pain intensity was similar between FPNS and placebo. At 5-to-60 min post-dose, patients receiving 800-mg FPNS reported higher pain intensity than patients receiving lower dosages. SPID at 5-to-60 min post-dose was larger for FPNS than placebo (SPID30, 8.5 vs. 4.5; P<.0001). SPID30 for patients receiving 800-mg FPNS was smaller than for patients receiving 100- or 200-mg (6.6 vs. 10.2; all P<.05), with similar results for SPID45 and SPID60. On average, 74% of patients reported being “satisfied” or “very satisfied” across all acceptability scores, with similar scores between patients receiving 100-to-800 mg FPNS. Overall, 50.7% of patients receiving FPNS reported adverse events AEs). AEs were typical of fentanyl, mostly mild-to-moderate in severity, and did not increase in frequency or severity with increasing FPNS dosage. Conclusion: FPNS was efficacious and accepted across all dosages, and higher dosages did not affect its safety and tolerability. This study suggests that FPNS provides rapid and effective analgesia, with a potential for range of dosages for treatment of BPTc.
Poster 129 Pain Relief and Its Impact on Sleep in Treatment of Neuropathic Pain Associated with Postherpetic Neuralgia Mark S. Wallace, MD, Brett B. Snodgrass, MSN, APRN, FNP-C, Jamie Massengill, MS, MHS, PA-C, Iwona Bucior, PhD (Depomed, Inc., Newark, CA, United States), Charles Argoff, MD Disclosures: I. Bucior: Employment - Depomed, Inc.; Stock Options or Bond Holdings - Depomed, Inc. Objective: To characterize factors defining responses in pain intensity and its interference with sleep, and their impact on overall outcomes in patients with postherpetic neuralgia (PHN) treated with gastroretentive gabapentin (G-GR; GraliseÒ). Design: Analysis of integrated data from randomized Phase 3 and open-label Phase 4 studies. Setting: At home with routine clinical visits.
Participants: Patients with PHN (n¼556). Interventions: After a 2-week titration, patients received G-GR 1800-mg once-daily for 8 (Phase 3) or 6 (Phase 4) weeks, followed by a 1-week dose tapering period. Main Outcome Measures: Visual Analog Scale (VAS), Brief Pain Inventory (BPI), and Patients’ Global Impression of Change (PGIC) completed at baseline and/or end-of-study. Responders were patients with 30% reduction in VAS pain or BPI sleep; Non-Responders patients with <30%. Results or Clinical Course: Responders in VAS or BPI sleep were mostly females (64.3-65.6%). Both Responder groups shared similar improvements across outcomes assessed on VAS, BPI, and PGIC. For all Responders, there was a linear correlation between percent reductions in VAS and BPI sleep interference (all P<.001). Being a Responder in VAS was not predictive of reporting significant changes in BPI sleep interference and vice versa. There were no differences between Responders and Non-Responders in frequency or severity of adverse events (AEs). More Non-Responders discontinued early due to AEs (17.9-18.4% vs. 9.0-9.3%, P<.01), mostly due to mild or moderate AEs. Conclusion: Reductions in pain or sleep interference were not predictive of each other, but were accompanied by parallel improvements in other treatment responses. Female sex seemed the only baseline characteristic contributing to better treatment responses in pain or sleep. Another important factor was early discontinuation due to AEs, but not AE severity, suggesting that patients’ ability to tolerate AEs and that better education about the safety profile may facilitate more successful treatment of PHN.
Poster 130 Ilioinguinal Nerve Block to Treat Complications of Hernia Repair: A Case Report Laura Davids (Stony Brook University, Little Neck, NY, United States), Susan M. Stickevers, MD, Yudell Edelstein, MD Disclosures: L. Davids: I Have No Relevant Financial Relationships To Disclose. Case Description: A 45-year-old man who underwent open herniorrhaphy with mesh placement one year prior presented with chronic right groin pain. Pain was described as “burning,” and was exacerbated by Valsalva maneuver and lumbar extension. On examination, pain was elicited on palpation over the inguinal ligament. No motor or sensory deficits were appreciated. Tinel’s sign was positive at the inguinal ligament. Patient was diagnosed with ilioinguinal neuralgia and scheduled for an ilioinguinal nerve block. Setting: Tertiary care hospital. Results or Clinical Course: Ilioinguinal nerve block was performed by identifying a point 2 inches medial and 2 inches inferior to the anterior superior iliac spine, and triamcinolone and lidocaine were injected at an oblique angle toward the pubic symphysis. The patient tolerated the procedure well and reported immediate relief of pain that lasted four months. Due to recurrence of groin pain, an ultrasound was performed which demonstrated no evidence of ilioinguinal nerve damage; however, a recurrent indirect inguinal hernia due to a mesh defect caused traction on the nerve when the patient stood upright. The patient was advised to return to his surgeon for revision surgery. Discussion: Inguinal hernia repair can result in injuries to the ilioinguinal, iliohypogastric, and genitofemoral nerves. Chronic groin pain following inguinal hernia repair has been reported in 5-22% of patients following surgery. Ultrasound is a useful technique as it provides dynamic imaging of the nerves and surgical site in multiple positions.
Abstracts / PM R 7 (2015) S83-S222
PAIN AND SPINE MEDICINE Poster 128 Dosage-Dependent Effectiveness of Treatment of Breakthrough Cancer Pain with Fentanyl Pectin Nasal Spray Jeannine M. Brant, PhD, APRN, AOCN, Iwona Bucior, PhD (Depomed, Inc., Newark, CA, United States), Florin Orza, MD Disclosures: I. Bucior: Employment - Depomed, Inc.; Stock Options or Bond Holdings - Depomed, Inc. Objective: To evaluate the effectiveness, acceptability, and safety of different dosages of Fentanyl Pectin Nasal Spray (FPNS; LazandaÒ) in treatment of breakthrough cancer pain (BTPc). Design: Analysis of data from two randomized Phase 3 studies. Setting: At home with routine clinical visits. Participants: Patients with cancer who were experiencing on average 1-4 episodes of BTPc per day. Interventions: 60 mg/day oral morphine (or equivalent) for background pain, and 100-, 200-, 400-, or 800-mg FPNS or matching placebo for BTPc. Main Outcome Measures: The primary efficacy endpoint was patientaveraged summed pain intensity difference at 30 min post-dose (SPID30). Secondary endpoints included: SPID at 5, 10, 15, 45, and 60 min post-dose; patient acceptability scores (overall satisfaction, speed of relief, reliability, ease of use, and overall convenience of the nasal spray). Results or Clinical Course: Mean baseline pain intensity was similar between FPNS and placebo. At 5-to-60 min post-dose, patients receiving 800-mg FPNS reported higher pain intensity than patients receiving lower dosages. SPID at 5-to-60 min post-dose was larger for FPNS than placebo (SPID30, 8.5 vs. 4.5; P<.0001). SPID30 for patients receiving 800-mg FPNS was smaller than for patients receiving 100- or 200-mg (6.6 vs. 10.2; all P<.05), with similar results for SPID45 and SPID60. On average, 74% of patients reported being “satisfied” or “very satisfied” across all acceptability scores, with similar scores between patients receiving 100-to-800 mg FPNS. Overall, 50.7% of patients receiving FPNS reported adverse events AEs). AEs were typical of fentanyl, mostly mild-to-moderate in severity, and did not increase in frequency or severity with increasing FPNS dosage. Conclusion: FPNS was efficacious and accepted across all dosages, and higher dosages did not affect its safety and tolerability. This study suggests that FPNS provides rapid and effective analgesia, with a potential for range of dosages for treatment of BPTc.
Poster 129 Pain Relief and Its Impact on Sleep in Treatment of Neuropathic Pain Associated with Postherpetic Neuralgia Mark S. Wallace, MD, Brett B. Snodgrass, MSN, APRN, FNP-C, Jamie Massengill, MS, MHS, PA-C, Iwona Bucior, PhD (Depomed, Inc., Newark, CA, United States), Charles Argoff, MD Disclosures: I. Bucior: Employment - Depomed, Inc.; Stock Options or Bond Holdings - Depomed, Inc. Objective: To characterize factors defining responses in pain intensity and its interference with sleep, and their impact on overall outcomes in patients with postherpetic neuralgia (PHN) treated with gastroretentive gabapentin (G-GR; GraliseÒ). Design: Analysis of integrated data from randomized Phase 3 and open-label Phase 4 studies. Setting: At home with routine clinical visits.
Participants: Patients with PHN (n¼556). Interventions: After a 2-week titration, patients received G-GR 1800-mg once-daily for 8 (Phase 3) or 6 (Phase 4) weeks, followed by a 1-week dose tapering period. Main Outcome Measures: Visual Analog Scale (VAS), Brief Pain Inventory (BPI), and Patients’ Global Impression of Change (PGIC) completed at baseline and/or end-of-study. Responders were patients with 30% reduction in VAS pain or BPI sleep; Non-Responders patients with <30%. Results or Clinical Course: Responders in VAS or BPI sleep were mostly females (64.3-65.6%). Both Responder groups shared similar improvements across outcomes assessed on VAS, BPI, and PGIC. For all Responders, there was a linear correlation between percent reductions in VAS and BPI sleep interference (all P<.001). Being a Responder in VAS was not predictive of reporting significant changes in BPI sleep interference and vice versa. There were no differences between Responders and Non-Responders in frequency or severity of adverse events (AEs). More Non-Responders discontinued early due to AEs (17.9-18.4% vs. 9.0-9.3%, P<.01), mostly due to mild or moderate AEs. Conclusion: Reductions in pain or sleep interference were not predictive of each other, but were accompanied by parallel improvements in other treatment responses. Female sex seemed the only baseline characteristic contributing to better treatment responses in pain or sleep. Another important factor was early discontinuation due to AEs, but not AE severity, suggesting that patients’ ability to tolerate AEs and that better education about the safety profile may facilitate more successful treatment of PHN.
Poster 130 Ilioinguinal Nerve Block to Treat Complications of Hernia Repair: A Case Report Laura Davids (Stony Brook University, Little Neck, NY, United States), Susan M. Stickevers, MD, Yudell Edelstein, MD Disclosures: L. Davids: I Have No Relevant Financial Relationships To Disclose. Case Description: A 45-year-old man who underwent open herniorrhaphy with mesh placement one year prior presented with chronic right groin pain. Pain was described as “burning,” and was exacerbated by Valsalva maneuver and lumbar extension. On examination, pain was elicited on palpation over the inguinal ligament. No motor or sensory deficits were appreciated. Tinel’s sign was positive at the inguinal ligament. Patient was diagnosed with ilioinguinal neuralgia and scheduled for an ilioinguinal nerve block. Setting: Tertiary care hospital. Results or Clinical Course: Ilioinguinal nerve block was performed by identifying a point 2 inches medial and 2 inches inferior to the anterior superior iliac spine, and triamcinolone and lidocaine were injected at an oblique angle toward the pubic symphysis. The patient tolerated the procedure well and reported immediate relief of pain that lasted four months. Due to recurrence of groin pain, an ultrasound was performed which demonstrated no evidence of ilioinguinal nerve damage; however, a recurrent indirect inguinal hernia due to a mesh defect caused traction on the nerve when the patient stood upright. The patient was advised to return to his surgeon for revision surgery. Discussion: Inguinal hernia repair can result in injuries to the ilioinguinal, iliohypogastric, and genitofemoral nerves. Chronic groin pain following inguinal hernia repair has been reported in 5-22% of patients following surgery. Ultrasound is a useful technique as it provides dynamic imaging of the nerves and surgical site in multiple positions.