Intravenous Patient-Controlled Analgesia with Esketamine Improves Early Depressive Symptoms in Patients with Postherpetic Neuralgia: A Single-Center Retrospective Cohort Study

doi:10.21203/rs.3.rs-4102452/v1

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Intravenous Patient-Controlled Analgesia with Esketamine Improves Early Depressive Symptoms in Patients with Postherpetic Neuralgia: A Single-Center Retrospective Cohort Study

https://doi.org/10.21203/rs.3.rs-4102452/v1

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published 27 Aug, 2024

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Objective

Patients with Postherpetic Neuralgia (PHN) often exhibit depressive-like symptoms, significantly impacting their quality of life. Esketamine, known for its analgesic properties, has also been recognized for its rapid antidepressant effects. However, its efficacy in the treatment of PHN requires further exploration. This study aims to evaluate the impact of intravenous patient-controlled analgesia with esketamine on depressive mood in PHN patients.

Methods

This retrospective study analyzed PHN patients hospitalized and treated at the affiliated hospital of Southwest Medical University from June 2021 to March 2023. Patients were divided into the esketamine group (E group) and the sufentanil group (S group) based on their treatment regimens. Primary outcomes included pain NRS, depression PHQ-9, and anxiety GAD-7 scores measured before treatment, and at 3 days, 7 days, 1 month, 2 months, and 3 months post-treatment.

Results

A total of 83 patients were included in the analysis. Before treatment, there were no statistically significant differences in pain NRS, depression PHQ-9, and anxiety GAD-7 scores between the two groups (P > 0.05). Compared to before treatment, significant reductions in pain NRS scores were observed at all post-treatment time points in both groups (P < 0.05), with no differences between groups (P > 0.05). The E group exhibited significantly lower depression PHQ-9 scores than the S group at 3 days and 7 days post-treatment (P < 0.05), but no significant differences were observed at 1 month, 2 months, and 3 months (P > 0.05). Anxiety GAD-7 scores were significantly lower in the E group compared to the S group at 3 days, 7 days, and 3 months post-treatment (P < 0.05), with no statistical differences at 1 month or 2 months post-treatment (P > 0.05).

Conclusion

Intravenous patient-controlled analgesia with esketamine not only alleviates pain in PHN patients but also improves early symptoms of anxiety and depression.

Esketamine

Postherpetic Neuralgia

Depression

Postherpetic Neuralgia (PHN) is a persistent pain condition following herpes zoster infection, considered one of the most severe complications of shingles. PHN not only causes constant pain but is also associated with significant psychological disorders, including anxiety and depression, which collectively reduce the quality of life of the patients [1, 2] and severely impact their personal and social functions [3]. Currently, treatment strategies for PHN mainly include pharmacotherapy, minimally invasive interventions, and physical therapy, among which pulsed radiofrequency [4] is widely used in clinical settings due to its minimal invasiveness, fewer complications, and non-destructive nature to nerves, effectively alleviating patient pain. However, the existing treatment methods have limited effects on relieving the anxiety and depression of PHN patients, highlighting the importance of addressing psychological disorders in the comprehensive treatment of PHN.

In recent years, esketamine has attracted widespread attention due to its dual functions of analgesia and rapid antidepressant effects [5–7]. As the S-enantiomer of ketamine, esketamine shows higher affinity and selective inhibition of the NMDA receptor, especially the selective inhibition of presynaptic NMDA receptors on the GluN2B subunit. Additionally, it exerts its antidepressant effects through inhibiting NMDA receptor-dependent neuronal burst firing and activating AMPA receptors [8]. The approval of esketamine nasal spray by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant depression [9] signifies its important position in the field of mental health treatment.

This study aims to explore the effects of intravenous patient-controlled analgesia with esketamine on pain, anxiety, and depressive mood in PHN patients, offering a new perspective and approach for the clinical treatment of neuropathic pain and providing a scientific basis for comprehensive treatment strategies for PHN patients.

Clinical Data

This retrospective observational study included patients diagnosed with Postherpetic Neuralgia (PHN) at the Department of Pain Management of the Affiliated Hospital of Southwest Medical University from June 2021 to March 2023.

Inclusion criteria were: (1) diagnosis of PHN according to the "Chinese Expert Consensus on Herpes Zoster" and the "Chinese Expert Consensus on Diagnosis and Treatment of Postherpetic Neuralgia"; (2) patients who signed informed consent for the relevant treatment; (3) patients who underwent pulsed radiofrequency treatment under ultrasound guidance; (4) patients treated with either sufentanil or intravenous patient-controlled analgesia with esketamine; (5) patients who completed pain (NRS score), depression (PHQ-9 score), and anxiety (GAD-7 score) assessments before treatment, and at 3 days, 7 days, 1 month, 2 months, and 3 months after treatment. Exclusion criteria included: (1) patients who refused to participate during outpatient or telephone follow-up; (2) patients lost to follow-up; (3) patients who did not complete pain (NRS score), depression (PHQ-9 score), and anxiety (GAD-7 score) assessments before and after treatment at specified times.

Sample size calculation

This cohort study's primary outcome, the NRS score, is a continuous variable. Sample size (N) was calculated using the formula N=[(Zα/2 + Zβ)^2σ^2(1 + 1/κ)]/δ^2, where σ is the pooled standard deviation, α is the difference between the means, Z represents the standard normal distribution, α is the Type I error probability, and β is the Type II error probability. Based on previous literature [10–11] and using PASS 2021 software, the sample size was calculated to be 40 cases per group, totaling 80 cases.

Pulsed Radiofrequency Treatment:

Targeting the affected nerve root under ultrasound guidance (Fig. 1), pulsed radiofrequency treatment was administered with specific parameters (70 V, 2 Hz, 20 ms, 42°C for 6 minutes, 45.0°C for 6 minutes).

Intravenous Patient-Controlled Analgesia:

Either sufentanil (100µg in 100ml saline) or esketamine (100mg in 100ml saline) was used for intravenous analgesia via a pump, set to a continuous infusion of 1ml/h, with patient-controlled analgesia (PCA) of 0.5ml per demand, and a lockout time of 30 minutes, continuously used for 3 days. If the pain NRS score exceeded 4, an additional intramuscular injection of 50mg tramadol hydrochloride was given as a rescue analgesic measure.

Data collection involved reviewing medical records for demographic information, medical history, PHN diagnosis details, NRS scores, and previous PHN treatment methods. Follow-up data collected during hospital stays, outpatient visits, or telephone follow-ups included pain (NRS score), depression (PHQ-9 score), anxiety (GAD-7 score), medication use, and any adverse events, all anonymized to protect patient privacy. Patients agreed to participate after being informed through outpatient services or telephone follow-ups, waiving the need for signed informed consent. NRS pain scores range from 0–10, with 0 indicating no pain, 1–3 light pain, 4–6 moderate pain, and 7–10 severe pain. PHQ-9 depression scores range from 0–4 for no depression, 5–9 for mild, 10–14 for moderate, 15–19 for moderately severe, and 20–27 for severe depression. GAD-7 anxiety scores range from 0–4 for no anxiety, 5–9 for mild, 10–14 for moderate, and 15–21 for severe anxiety.

Observation Indicators Primary outcomes:

Pain NRS, depression PHQ-9, and anxiety GAD-7 scores before treatment and at each time point after treatment. Secondary outcomes: Patient demographic information, medical history, PHN diagnosis, previous PHN treatment methods, and adverse reactions.

Statistical Analysis

Data processing and statistical analysis were performed using SPSS 26.0 and GraphPad Prism 9.0 software. Quantitative data following a normal distribution were presented as mean ± standard deviation and compared using t-tests or one-way ANOVA for inter-group comparisons, while non-normally distributed quantitative data were compared using the T-test or Mann-Whitney U test for inter-group comparisons, and the Friedman rank sum test for intra-group comparisons. Categorical data were compared using the Chi-square test. P < 0.05 was considered statistically significant.

Patient Baseline Characteristics

Between June 2021 and March 2023, a total of 90 patients diagnosed with Postherpetic Neuralgia (PHN) were initially included in this study. Of these, 3 patients were excluded due to loss of contact through outpatient visits or telephone, 2 patients refused to participate during telephone or outpatient follow-ups and were excluded, and 2 patients were excluded due to incomplete assessment information. Thus, the retrospective analysis ultimately included 83 patients, with 40 in the sufentanil group (S group) and 43 in the esketamine group (E group) (as shown in Fig. 2). A comparison of general characteristics such as gender, age, affected side, causative segments, comorbidities, and onset time between the two groups showed no statistically significant differences in these general characteristics and clinical factors (P > 0.05, see Table 1 for details).

Table 1

Clinical characteristics of the two groups (x ± SD)
Group	S	E	P
Male/Female	23/17	22/21	0.563
Age(years)	69.95 ± 11.9	68.63 ± 10.09	0.590
Affected side(Left/Right)	18/22	26/17	0.158
Pathogenic segment
Cephalic and Cervical segment	14(35%)	14(32.6%)	0.814
Thoracic segment	24(60%)	26(60.5%)	0.965
Lumbar segment	2(5%)	3(6.9%)	0.705
Comorbidity	11/29	12/31	0.967
Hypertension	14	13	0.484
Coronary Heart Disease	2	5	0.167
Diabetes	11	10	0.657
Time of onset(month)	1.000[1.000,4.000]	1.000[1.000,3.000]	0.277

Comparison of Pain NRS, Depression PHQ-9, and Anxiety GAD-7 Scores

Between the Groups Compared to before treatment, both groups showed a significant decrease in pain NRS scores at 3 days, 7 days, 1 month, 2 months, and 3 months after treatment, but there was no statistical difference between the groups at any time points after treatment (P > 0.05) (Fig. 3A). The esketamine group (E group) had significantly lower PHQ-9 scores than the sufentanil group (S group) at 3 days and 7 days post-treatment (P < 0.05). There was no significant difference in PHQ-9 scores between the groups at 1 month, 2 months, and 3 months after treatment (P > 0.05) (Fig. 3B). The E group also showed significantly lower GAD-7 scores than the S group at 3 days, 7 days, and 3 months post-treatment (P < 0.05), with no observed statistical difference between the groups at 1 month and 2 months post-treatment (P > 0.05) (Fig. 3C).

Comparison of Daily Oral Doses of Pregabalin, Tramadol Capsules, and Adverse Reactions Between the Groups

As depicted in Fig. 4, there were no statistically significant differences in the daily doses of pregabalin between the two groups at any time points before and after treatment (3 days, 7 days, 1 month, 2 months, and 3 months) (P > 0.05). Three patients in the S group and five in the E group required tramadol for pain relief, with no statistical difference observed (P = 0.206) (Table 2). Two instances of dizziness were reported in the S group, compared to three in the E group, with no statistical difference (P = 0.705) (Table 2).

Table 2

Adverse reactions of patients in both groups
Group	S	E	P
Dizziness	2	3	0.705
Required tramadol for pain relief	3	5	0.206

Postherpetic neuralgia (PHN) represents a classic example of neuropathic pain. Persistent pain significantly impacts the emotional well-being of patients, with those suffering from PHN often experiencing varying degrees of anxiety and depression. These psychological states can exacerbate pain, creating a vicious cycle of mutual reinforcement [12–13].

This retrospective observation found that all hospitalized patients receiving pulsed radiofrequency treatment in conjunction with either sufentanil or esketamine intravenous patient-controlled analgesia showed significant reductions in their pain NRS scores over a follow-up period of up to three months. This demonstrates the enduring analgesic effectiveness of combining pulsed radiofrequency with sufentanil or esketamine intravenous patient-controlled analgesia for PHN patients. Despite some patients experiencing mild pain recurrence 1–3 months post-treatment, the majority were satisfied with the treatment outcomes. Pulsed radiofrequency, a minimally invasive treatment widely used in recent years for chronic neuropathic pain, operates by transmitting electric currents to nociceptive nerve fibers, thereby inhibiting pain transmission [14–16]. Opioid analgesics like sufentanil, known for their potent pain-relieving capabilities, primarily exert their analgesic effects by specifically binding to µ-opioid receptors and diffusing into tissues [17]. Esketamine, the S-enantiomer of ketamine, primarily exerts its sedative and analgesic effects through interactions with monoamine, opioid receptors, and N-methyl-D-aspartate (NMDA) receptors [18]. Moreover, intravenous infusion of ketamine for the treatment of refractory pain is supported by guidelines from the American Society of Anesthesiologists and the Pain Society [19].

Esketamine's significant reduction in PHQ-9 scores at 3 and 7 days post-treatment, with no significant change from 1 to 3 months, indicates its rapid anti-depressant-like action has a marked therapeutic effect on early depressive states in PHN patients, possibly due to the short duration of anti-depressant effects following a single administration of esketamine intravenous patient-controlled analgesia. Furthermore, this retrospective observation noted significant reductions in GAD-7 scores at 3 days, 7 days, and 3 months post-treatment, suggesting esketamine's potential anti-anxiety effects. Ketamine is a non-competitive antagonist of the N-methyl-D-aspartic (NMDA) receptor [20–21]. Its binding to the NMDA receptor inhibits the phosphorylation of eukaryotic elongation factor 2, promotes the release of brain-derived neurotrophic factor (BDNF), and by inducing the mammalian target of rapamycin1 (mTORC1) signaling pathway and activating extracellular regulated protein kinases (ERK), it improves neural plasticity and synaptic formation [22–23], thus exerting antidepressant effects. Esketamine, an enantiomer of R-ketamine, exhibits 3 to 4 times the affinity for the NMDA receptor compared to R-ketamine, and twice that of ketamine [24]. In March 2019, the Food and Drug Administration (FDA) approved the esketamine nasal spray developed by Johnson & Johnson for use in conjunction with oral antidepressants in treating treatment-resistant major depressive disorder in adults [25–26].

Regarding the safety of esketamine's clinical application, this retrospective observation reported only two cases of dizziness in the esketamine group compared to three in the sufentanil group, with no significant difference in adverse effects between the groups. This suggests the safety and feasibility of using esketamine intravenous patient-controlled analgesia in treating PHN. Analysis of adverse reactions reported to the FDA's adverse event reporting system within one year of the market release of esketamine nasal spray found common adverse effects including nausea, vomiting, dizziness, and elevated blood pressure, with a total of 962 patients reporting 2274 esketamine-related adverse events, of which dizziness accounted for only 389 cases [27–30], indicating the nasal spray's good safety profile. No cases of drug addiction were reported, either during administration or after cessation of treatment, whether with single or repeated dosing [31].

This project marks the first retrospective analysis of esketamine's efficacy in treating PHN, but it has its limitations: the sample size is relatively small; the follow-up period is relatively short; it lacks exploration into the underlying mechanisms, with observation indicators primarily based on subjective scales and lacking objective metrics, introducing potential bias in methodology. Thus, this project serves as a retrospective exploration, revealing that esketamine intravenous patient-controlled analgesia combined with pulsed radiofrequency treatment can alleviate pain and improve early symptoms of anxiety and depression in PHN patients. However, these findings necessitate further confirmation through large-scale, multicenter, prospective randomized controlled trials in the future.

Ethics approval and consent to participate

The application of intravenous analgesia with esketamine (KY2021299) and this retrospective study (KY2023001) were both approved by the Ethics Committee of the Affiliated Hospital of Southwest Medical University, in accordance with the Declaration of Helsinki. All participants were informed about their participation in this study through outpatient services or telephone follow-up, and the requirement for signed informed consent was waived for this retrospective study. This research was also registered with the China Clinical Trial Registry (ChiCTR2300069263).

Consent for publication

All authors have provided their verbal consent for publication.

Availability of data and materials

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. All data were stored and analyzed using secure, password-protected systems to ensure confidentiality.

Competing interests

The authors state that they conducted the research without any commercial or financial relationships that might be considered a potential conflict of interest.

Funding

No funding.

Authors' contributions

Xiaobin Wang designed the study. Ling Qiu, Xuhui Chen, Jia Fu, and Xingqu Chen analyzed the data and drafted the manuscript participated in the critical discussion and revision of the article. All authors contributed to the article and approved the submitted version.

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No competing interests reported.

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published 27 Aug, 2024

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You are reading this latest preprint version

Intravenous Patient-Controlled Analgesia with Esketamine Improves Early Depressive Symptoms in Patients with Postherpetic Neuralgia: A Single-Center Retrospective Cohort Study

Status:

Journal Publication

Version 1

Abstract

Objective

Methods

Results

Conclusion

Figures

Introduction

Materials and Methods

Clinical Data

Sample size calculation

Pulsed Radiofrequency Treatment:

Intravenous Patient-Controlled Analgesia:

Observation Indicators Primary outcomes:

Statistical Analysis

Results

Patient Baseline Characteristics

Comparison of Pain NRS, Depression PHQ-9, and Anxiety GAD-7 Scores

Comparison of Daily Oral Doses of Pregabalin, Tramadol Capsules, and Adverse Reactions Between the Groups

Discussion

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1