Risk factors of pain in radiofrequency ablation for varicose veins of the lower extremity

doi:10.21203/rs.3.rs-4620203/v1

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Research Article

Risk factors of pain in radiofrequency ablation for varicose veins of the lower extremity

https://doi.org/10.21203/rs.3.rs-4620203/v1

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Objective

Radiofrequency ablation (RFA) is the recommended first line intervention for varicose veins of the lower extremity. While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort.this study focused on patients who experience pain during the TLA process in RFA surgery, analyzed the risk factors that leading to the pain.

Methods

This study is a single-center prospective observational study, During the period from April 2023 to September 2023, a total of 155 patients underwent RFA of great saphenous vein(GSV)/small saphenous vein(SSV). Clinical basic data of the patients were collected. All patients were assessed for Clinical Etiologic Anatomic Pathological (CEAP) classification and GSV/SV diameter was recorded using ultrasound measurements. The surgical procedure involved RFA of the GSV/SSV trunk, recording patients' visual analog scale (VAS) score at four time points during RFA (local anesthesia, injection of tumescent solution, RFA working, end of RFA).

Results

A total of 155 patients were included in the study, with median pain scores of 5 (4, 6) at the time of local anesthesia and injection of tumescent solution, Over 80% of patients had mild to moderate pain.Most of patients had no pain when RFA working and the end of RFA .Male patients experienced higher levels of pain than female patients during TLA (P < 0.01); lower operating room temperature during TLA was associated with higher pain levels (P < 0.01); there was no significant correlation between female childbirth history, BMI, CEAP classification and puncture site (P > 0.05).

Conclusion

Most patients can tolerate the pain during TLA, with a few patients experiencing severe pain but still able to endure until the RFA is completed. At the end of RFA most patients feel no pain, while a very small number of patients have mild pain. The pain during RFA procedures is related to gender and operating room temperature; it is not related to female childbirth history, CEAP classification, BMI and puncture site.

Radiofrequency ablation

Anaesthesia

Surgery

Varicose veins

Visual analogue scale

Traditionally, surgery represented by high ligation and stripping has been the preferred method for treating lower limb varicose veins(VVs), but there are adverse effects such as relatively high trauma, slow recovery and obvious incision scar, which reduces surgical satisfaction[1, 2]. In recent years, with the promotion of the concept of minimally invasive surgery, the treatment of lower limb VVs through intervention has been widely recognized[3].

Now RFA is the recommended first line intervention for symptomatic superficial venous incompetence (SVI)[4, 5].Numerous studies have demonstrated the short-term superiority of this modality, over conventional surgery in terms of quicker recovery, technical efficacy, and patient reported outcome measures (PROMs) including pain, satisfaction, and quality of life[6–11].

RFA treatment combining minimally invasive stripping surgery can be performed under tumescent local anaesthesia while the patient is awake, reducing the possibility of anesthesia complications, which is another advantage[12–14]. However, performing tumescent local anaesthesia requires multiple injections along the GSV/SSV region, especially when the patient is awake, which is one of the main causes of pain during the surgery[15], and previous studies have also shown that adding additional anesthesia is needed to alleviate the pain throughout the procedure[16, 17]. Therefore, this study focused on patients who experience pain during the TLA process in RFA surgery, we analyzed the risk factors that leading to the pain and laid the groundwork for establish a nomogram model for predicting intraoperative pain during RFA for VVs.

Participants

A total of 155 limbs in 155 patients who underwent RFA under TLA while conscious during April 2023 and September 2023 were enrolled in this study. This research protocol has been approved by the local ethics committee(2023KL-015) and has obtained informed consent from all patients. In this study, patients with VVs meet the updated diagnostic criteria for varicose veins in the lower extremities by the 2020 American Venous Forum and the CEAP classification [18].

Study inclusion criteria specified patients with primary unilateral symptomatic superficial venous incompetence attributable to saphenofemoral junction (SFJ)/Saphenopopliteal junction (SPJ) and GSV/SSV reflux on DUS examination; incompetence was defined as reflux of at least 1 s on spectral Doppler analysis. Patients meeting these criteria, with clinical grades C2-C6 of the CEAP classification system[19], deemed suitable to undergo RFA, were identified for trial inclusion. Patients agreed to join this study and signed the informed consent form.

Exclusion criteria : Patients with lower extremity arterial ischemia with an ABI (ankle-brachial index) ≤ 0.8;Exclusion criteria were an alternative (non-GSV) axis of incompetence, bilateral disease, when RFA was not deemed technically feasible, for patients unwilling or unable to consent or participate in the study or follow up, pregnancy or within 6 months postpartum, previous ipsilateral deep venous thrombosis (DVT), isolated deep venous incompetence, active or recent thrombophlebitis (within the last 6 weeks), previous ipsilateral varicose vein treatment, or known peripheral arterial disease with impalpable foot pulses and ankle brachial pressure index < 0.8.Patients with a previously implanted pacemaker or defibrillator who were currently on routine anticoagulation therapy.

Tumescent local anaesthesia

The TLA solution was made as per the authors’ standard currently used solution: 1 L bag 0.9% sodium chloride, 100 mL extracted to leave 900 mL, to which 100 mL 1% lidocaine with 1:200,000 epinephrine was added. This therefore gave a solution of 1% lidocaine with 1:2,000,000 epinephrine. with the addition of 10 mL 8.4% sodium bicarbonate[20].This tumescent solution is widely used in several applications in routine surgical and dermatological procedures, including endovenous thermal ablation (EVTA).

Standard RFA technique

The entire process of RFA surgery was performed under ultrasound guidance using ClosureFast™ (Medtronic Inc.) catheters. Before RFA procedure, real-time temperature in the operating room was recorded. Then the patient’s leg was prepped with iodine solution for routine disinfection and draped in a sterile fashion. Under ultrasound guidance, the puncture point was determined based on the actual depth of VV, and the puncture point was recorded as above or below the popliteal crease. Local anesthesia was administered at the puncture point using 1% lidocaine injection,VAS was performed at this time (recorded as VAS-1). After successfully puncturing the GSV/SSV with a 20G needle, a 7F sheath was implanted.The RFA catheter was accessed with The sheath, RF catheter implanted 2cm away from SFJ/SPJ,Then the tumescent solution was used throughout the entire length of the GSV/SSV for TLA, ensuring that the tumescent solution completely enveloped the GSV/SSV, and Visual Analogue Scale (VAS) was performed at this time (recorded as VAS-2) to assess the level of pain during puncturing and tumescent solution injecting. During the RFA procedure. Radiofrequency generated high temperature of 120 ° with a power of 40W. RFA was performed in line with the manufacturer’s recommendations, with two treatment cycles delivered to Each segment and VAS-3 was recorded at this time to assess the level of pain during RFA working. At the end of the RFA, VAS-4 was recorded.

Study design and statistical analysis

The following characteristics were analyzed at the time of diagnosis: demographic Characteristics, basic disease feature, body mass index (BMI), CEAP classification, number of childbirths for women, diameter of GSV /SSV, operating room temperature, tumescent solution temperature, length of RFA procedure and puncture site.

Statistical methods: SPSS 27.0 software was used for data processing and analysis. Count data was described using frequency and percentage, and the comparison between groups was performed using chi-square test. Normality test was conducted for continuous data, and data that followed a normal distribution were presented as mean ± standard deviation. The comparison between groups was performed using t-test or t'-test. If the data did not follow a normal distribution, the median M (P25, P75) was used, and non-parametric tests were used for group comparison. A p-value < 0.05 was considered statistically significant.

1 Baseline data

A total of 155 patients were included were included in this study between April 2023 to September 2023. All patients underwent RFA under TLA. The baseline variables of the patients was showned in Table 1.

Table 1

Demographic characteristics of the patients
		n = 155
Age (y)		57.93 ± 13.53
BMI(kg/m²)		24.05 ± 3.00
Male (n, %)		50(32.3)
Hypertension (n, %)		27(17.4)
Diabetes (n, %)		14(9.0)
Heart diseases		9(5.8)
Smoking (n, %)		14(9.0)
Number of childbirths for women [M(p25, p75)]		1(1,2)
CEAP Classification (n, %)
C2-C3		119(76.8)
C4-C6		36(23.2)
GSV(n, %) SSV(n, %) SFJ Diameter of GSV(mm)		126(81.3) 29(18.7) 8.04± 3.06
SPJ Diameter of SSV(mm)		4.61 ± 2.33
Operating room temperature (℃)		21.68 ± 1.70
Length of RFA procedure (cm)		28.75 ± 8.62
Puncture site (n, %)
Above the popliteal crease		90(58.1)
Below the popliteal crease		65(41.9)
GSV (Great saphenous vein;BMI:Body Mass Index);CEAP ( Clinical Etiologic Anatomic Pathologica)
2 Visual analog scale (VAS)

All patients' visual analog scale (VAS) scores were recorded at four time points during RFA (local anesthesia, injection of tumescent solution, RFA working and end of RFA) in Fig. 1.The VAS scores of patients during local anesthesia and injection of the tumescent solution(Fig. 1a.1b) were higher than those when the RFA working and end of RFA (Fig. 1c.1d). After statistical analysis, there was a statistically significant difference in the VAS scores at four time points during the RFA (P < 0.001).(Fig. 1)

Injecting tumescent solution is key to the RFA surgery. Pain score recording is in the second stage(VAS-2). Based on the score, we divided the patients into two groups: mild pain group (score less than or equal to 5) and pain group (score greater than 5). Comparing the baseline information of the two groups(Table 2), we found that male gender and operating room temperature were the risk factors affecting pain(Table 3).

Table 2

Baseline data comparison when injection of tumescent solution(VAS−2)
	VAS ≤ 5 (n = 94)		Total (n = 155)
Demographic characteristics
Age (y)	58.86 ± 10.15	56.45 ± 17.62	57.93 ± 13.49
BMI (kg/m2)	24.34 ± 2.96	23.60 ± 3.04	24.05 ± 2.99
Male (n, %)	21(22.1),	29(48.3)	50(31.8)
Number of childbirths for women [M(p25, p75)]	1(1,2)	2(1,2)	1(1,2)
Hypertension (n, %)	12(12.6)	15(25.0)	27(17.1)
Diabetes (n, %)	7(7.4)	7(11.7)	14(8.9)
Heart diseases (n, %)	5(5.3)	4(6.7)	9(5.7)
Smoking (n, %)	5(5.3)	9(15.0)	14(8.9)
CEAP Classification (n, %)
C2-C3	71(74.7)	48(80.0)	119(75.7)
C4-C6	24(25.3)	12(20.0)	36(22.9)
SFJ Diameter of GSV (mm)	8.36 ± 3.41	7.55 ± 2.39	8.04 ± 3.06
SPJ Diameter of SSV (mm)	5.10 ± 2.61	3.83 ± 1.56	4.61 ± 2.33
Operating room temperature (℃)	21.89 ± 0.70	21.33 ± 0.54	21.68 ± 0.70
Tumescent solution temperature (℃)	23.67 ± 1.06	23.75 ± 1.14	23.70 ± 1.08
Length of RFA procedure (cm)	29.22 ± 8.95	28.02 ± 8.18	28.75 ± 8.62
Puncture site (n, %)
Above the popliteal crease	50(52.6)	40(66.7)	90(58.1)
Below the popliteal crease	45(47.4)	20(33.3)	65(41.9)

Table 3

Risk factors for pain injection of tumescent solution(VAS−2)
	β	SE	OR	P
Operating room temperature	−1.684	0.346	0.186(0.094–0.366)	< 0.001
Male	1.570	0.443	4.805(2.018–11.441)	< 0.001

The results of this group's experiments indicate that it is feasible to perform lower limb varicose vein surgery on 155 patients under local anesthesia. Most patients did not experience discomfort, with pain scores generally acceptable. However, some patients still felt pain, particularly during the local anesthetic injection, which requires further analysis and improvement. RFA,as a minimally invasive surgical method, can be performed under local anesthesia, and most patients prefer this type of anesthesia, allowing them to remain conscious throughout the entire procedure. Therefore, the patient's experience during the operation is of utmost importance, and pain, as one of the most direct sensations experienced by patients during local anesthesia procedures, is influenced by multiple factors.

This study found that during RFA procedures, patients' pain was mainly concentrated on the first two stages: local anesthesia and injection of tumescent solution. Over 80% of the patients experienced mild or moderate pain, A minority of patients, despite experiencing severe pain, could also endure it through the surgeon's soothing or by diverting their attention away from the procedure. Pain during local anesthesia primarily arises from the puncture needle breaking through the skin and insertion into the vessel sheath. In this study, 7F sheath was used in RFA procedures, with a puncture needle diameter of 1.27mm. The pain sensation felt upon piercing the skin is stronger compared to that experienced when injecting via a syringe or intramuscularly, as reported in a well-designed randomized controlled trial [21]. The use of an automated injection device standardized the injection parameters, revealing that using a 0.16mm needle significantly reduced pain compared to a 0.26mm needle. Using smaller needles also compelled the injector to slow down the injection speed, thus reducing patient discomfort [22–25]. Therefore, in this study local anesthesia was performed around the puncture site using a 0.7mm needle, which can reduce the pain for patients. After local anesthesia, it can alleviate the pain when the sheath passes through the skin into the vessel. Similarly, injecting the swelling fluid via a 0.7mm needle along the main trunk of the GSV/SSC from the puncture site would result in an increased number of punctures as the patient's length of ablation increases. However, patients do not experience an increase in pain with each puncture; operators can alleviate the discomfort associated with injecting the swelling fluid by squeezing, pressing, stretching the skin, and inserting the needle vertically [26]. In the RFA working and the end of RFA more than 90% of patients experience no pain. Among those who do feel pain during the RFA working, ten patients experience mild discomfort. Patient anxiety, residual pain from injecting the swelling fluid, inadequate encapsulation of the main trunk of GSV/SSV, and other factors may lead to pain during the RFA working.However, this mild discomfort does not affect their daily activities, and no analgesics are required.

Many scholars have conducted relevant research on alleviating pain during local anesthesia surgery. A study[27] on the implantation of a cardiac pacemaker under local anesthesia found that the preoperative anxiety level of patients was related to intraoperative pain. Psychological factors, as subjective reasons, can to some extent alleviate or exacerbate the pain of patients during local anesthesia surgery. Therefore, doctors can comfort and encourage patients during surgery, relieve patients' tension, or distract patients' attention through chatting and playing music to reduce the pain of patients during RFA surgery. In a study[28] on the use of topical anesthetics to reduce pain during venipuncture, applying a local anesthetic cream containing 2.5% prilocaine and 2.5% lidocaine to the venipuncture area can significantly reduce the pain during venipuncture. However, the main drawback is that it must be applied on the skin for a long time to be effective, taking a total of 90 to 120 minutes to reach maximum effect[29]. Ice application before needling can also reduce pain. In dental clinical trials, ice application is commonly used to reduce pain when needles are inserted into the mucosa[30]. A study[31] comparing the effects of topical anesthetics and ice application before needling showed that topical anesthetics can better reduce pain, but their slow onset hinders their effectiveness. Ice application, on the other hand, is inexpensive, fast-acting, easily accessible, and still statistically significant in reducing pain. However, the area of the lower limb varicose vein surgery is large, and preoperative ice application is difficult and not easy to achieve. Other topical anesthetics (such as lidocaine gel, prilocaine gel, etc.) can be applied to the surgical area skin for relevant clinical trials to compare and analyze drugs with fast onset time and good anesthetic effects, thereby improving surgical details and reducing the pain of patients during surgery.

Numerous clinical studies and epidemiological evidence suggest that women are more sensitive to pain than men [32], with lower pain thresholds and poorer tolerance for pain [33]. A related report states that the prevalence of chronic pain in women is twice that of men [34], and in certain pain conditions, female patients require higher doses of analgesics compared to their male counterparts [35]. However, our study findings indicate that during the local anesthesia and injection of tumescent solution, males experienced greater pain levels than females. The differences between the two groups extend beyond just the intensity of pain but may also encompass its duration and other discomfort sensations. However, this study did not delve into a detailed comparison of these disparities. A recent systematic review concluded that there have been no clear and consistent findings regarding gender differences in human pain sensitivity across experimental studies conducted over the past decade [36], with pain disparities between genders being a complex phenomenon potentially influenced by multiple factors, including hormonal levels, psychological, and socio-cultural mechanisms that can affect both sexes' perception, expression, and tolerance of pain, thus blurring analyses of pain related to gender.In addition, we also investigated the relationship between the number of deliveries in female patients and pain, and found no significant difference between the two.

The appropriate operating room temperature can not only ensure a sterile environment during surgery, but also directly affect the comfort and pain level of patients. This study found through observation and analysis that there is a significant correlation between the temperature of the operating room and the level of pain experienced during local anesthesia and injection of tumescent solution. The lower the operating room temperature, the higher the level of pain experienced by patients. This may be related to factors such as vasoconstriction, slowed nerve conduction velocity, and muscle tension caused by cold stimulation[37]. Healthcare providers can create a more comfortable surgical environment for patients and effectively reduce intraoperative pain by adjusting the operating room temperature appropriately. This can improve patient satisfaction, demonstrating not only medical humanistic care but also a necessary requirement for the development of modern medical technology.

Different puncture sites involve different nerves and muscle tissues [38], and the tissue structure in the knee joint area is more complex, with a denser distribution of blood vessels, further affecting the patient's pain perception. However, the puncture points are basically around the knee joint in this group, so there were no significant differences in this group of experiments.BMI, as an important indicator of measuring the degree of obesity in the human body, is closely related to the occurrence and development of various diseases. This study indicates that BMI classification is not related to pain in patients undergoing RFA surgery. However, obese patients may have pathological changes such as thickening of blood vessel walls and decreased vascular elasticity. Future research can further explore the impact of BMI on the efficacy and complications of RFA treatment for lower extremity varicose veins.The CEAP classification system for CVD is widely used in the assessment of lower extremity varicose veins. Although the severity of the disease is believed to affect surgical pain[39].In this study,there was no statistical association between CEAP classification and pain at four stages during surgery.

Most patients can tolerate the pain under TLA. A few patients experience severe pain but can still persist until the surgery is completed. Most patients have no pain when the RFA working and the end of surgery, while a very small number of patients may experience mild pain. The pain during RFA procedure is related to gender, operating room temperature,but not related to female childbirth history, CEAP classification, BMI and puncture site .

Authors' contributions

Conception and design: LFZ,QQ and CSH.

Analysis and interpretation: LFZ, QFY,CYX and CJG.

Data collection: CYX, QFY, YL, CJG,JYZ and QQ.

Writing the article: LFZ,QFY and CJG.

Critical revision of the article: LFZ, QFY , QQ and CSH .

Final approval of the article: LFZ, QFY,CJG, YL, CYX, JYZ, WZ,QQ and CSH.

Statistical analysis: YL,QFY,CYX,JYZ and WZ.

funding: N/A.

Competing interests: N/A.

Ethical Approval: This study has been approved by the ethics committee of Hospital of Chengdu University of Traditional Chinese Medicine (2023KL-015) .

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No competing interests reported.

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Risk factors of pain in radiofrequency ablation for varicose veins of the lower extremity

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Abstract

Objective

Methods

Results

Conclusion

Figures

Introduction

Methods

Participants

Tumescent local anaesthesia

Standard RFA technique

Study design and statistical analysis

Results

1 Baseline data

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1