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- Title
Sequential administration of peripheral nerve blocks and onabotulinumtoxinA for the treatment of chronic migraine and other headache disorders—A retrospective tolerability and safety study.
- Authors
Anderson, Christopher C.; Iser, Courtney R.; Hirte, Ingrid L.; Boddu, Sayi; Girardo, Marlene E.; VanderPluym, Juliana H.; Starling, Amaal J.
- Abstract
Objective: To determine the tolerability and safety of concurrent peripheral nerve blocks and onabotulinumtoxinA treatment during a single outpatient clinic procedure visit. Background: Procedural interventions are available for the treatment of headache disorders. OnabotulinumtoxinA and peripheral nerve blocks are used as alternatives or in addition to oral therapies to reduce the frequency and intensity of migraine attacks. There is currently a lack of safety data focusing on the sequential administration of local anesthetic via peripheral nerve blocks and onabotulinumtoxinA during a single clinical encounter for the treatment of headache. The primary aim of the study was to determine the safety and tolerability of concurrent peripheral nerve blockade and onabotulinumtoxinA injections during a single outpatient clinic procedure visit. We hypothesized that the dual intervention would be safe and well tolerated by patients with chronic migraine and other headache disorders. Methods: A retrospective chart review was performed using clinical data from patients seen by multiple providers over a 16‐month timeframe at one outpatient headache clinic. Patients were identified by procedure codes and those receiving peripheral nerve block(s) and onabotulinumtoxinA injections during a single encounter within the study period were eligible for inclusion. Inclusion criteria were (1) patients 18 years and older who were (2) receiving both peripheral nerve blocks and onabotulinumtoxinA injections for the treatment of chronic migraine. Patients were excluded if they were under age 18, received their procedure outside of the clinic (emergency room, inpatient ward), or were receiving sphenopalatine ganglion blocks. Age‐ and sex‐matched patients who received one procedure, either peripheral nerve blocks or onabotulinumtoxinA, were used for control. The primary outcome of this safety study was the number of adverse events that occurred in the dual intervention group compared to the single intervention control arms. Information regarding adverse events was gathered via retrospective chart review. If an adverse event was recorded, it was then graded by the reviewer utilizing the Common Terminology Criteria for Adverse Events ranging from Grade 1 Mild Event to Grade 5 Death. Additionally, it was noted whether the adverse event led to treatment discontinuation. Results: In total, 375 patients were considered eligible for inclusion in the study. After age and sex matching of controls, 131 patients receiving dual intervention were able to be compared to 131 patients receiving onabotulinumtoxinA alone and 104 patients receiving dual intervention were able to be compared to 104 patients receiving peripheral nerve block(s) alone. The primary endpoint analysis showed no significant difference in total adverse events between dual intervention compared to nerve blocks alone or onabotulinumtoxinA alone. The number of adverse events that led to treatment discontinuation approached but did not reach statistical significance for those receiving dual intervention versus onabotulinumtoxinA alone in the number of adverse events that led to treatment termination (4.6%, 6/131 vs. 0.8%, 1/131, p = 0.065); however, the number of patients who discontinued therapy was not significantly different between those groups (2.3%, 3/131 vs. 0.8%, 1/131; p = 0.314; odds ratio 0.3 [0–3.2]; p = 0.338). Conclusions: In this retrospective chart review, there was no significant difference in adverse events or therapy discontinuation between patients receiving sequential peripheral nerve block(s) and onabotulinumtoxinA injections versus those receiving either peripheral nerve block(s) or onabotulinumtoxinA injections alone. As a result, we concluded that the combination procedure is likely safe and well tolerated in routine clinical practice. Plain Language Summary: At our headache center, we reviewed 366 patient charts for those receiving onabotulinumtoxinA, nerve blocks with local anesthetic, or both in the same visit for chronic migraine. Our goal was to compare the safety of performing both procedures at once versus each individual procedure. We found that the combination treatment with both injections of onabotulinumtoxinA and nerve blocks with local anesthetic for chronic migraine in the same appointment is well tolerated by patients.
- Subjects
PERIPHERAL nervous system; LOCAL anesthetics; PATIENT safety; MUSCLE relaxants; TREATMENT effectiveness; RETROSPECTIVE studies; HOSPITAL emergency services; DESCRIPTIVE statistics; ODDS ratio; BOTULINUM toxin; MEDICAL records; ACQUISITION of data; CLINICS; COMPARATIVE studies; MIGRAINE; NERVE block; PHARMACODYNAMICS
- Publication
Headache: The Journal of Head & Face Pain, 2024, Vol 64, Issue 6, p663
- ISSN
0017-8748
- Publication type
Article
- DOI
10.1111/head.14725