Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

November 15, 2024 updated by: Chunshui He, Chengdu University of Traditional Chinese Medicine
Objective: This study is a single-center prospective observational research that recorded patients' pain scores at four time points during surgery (puncture and catheter insertion, swelling fluid injection, microwave generator operation, and end of surgery). It analyzed the correlation between pain during microwave ablation treatment for great saphenous vein varicosities and factors such as age, gender, body mass index, volume of swelling fluid used, and others, in order to summarize and improve surgical details to reduce patients' intraoperative pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Despite the significant progress made by global experts in vascular surgery in studying endovenous microwave ablation (EMA) for the treatment of varicose veins (VVs), there are still many unknown areas to be explored. Current research primarily focuses on the surgical outcomes and associated complications of EMA, while studies on intraoperative pain are relatively scarce. Firstly, the American College of Radiology has not provided a clear definition of intraoperative pain when treating lower extremity varicose veins, thus it has not received sufficient attention in clinical practice. Many physicians consider the success of the surgery as the endpoint of treatment, overlooking the impact of intraoperative pain on the patient's surgical experience. Ni Zhao et al. found in a prospective randomized controlled trial that EMA is associated with more pain within 48 hours post-operation. When our department introduced the use of EMA for VVs, we discovered that its working form and power differ from other thermal ablations, and there are also differences in terms of intraoperative pain, the volume of tumescent fluid used, and the requirements for vein depth. With the continuous advancement in lower limb varicose vein surgeries, anesthesia methods have evolved from general anesthesia to combined spinal-epidural anesthesia, and now to local anesthesia. Tumescent anesthetic solution is the main anesthetic agent for EMA surgery, and the infiltration of tumescent anesthetic fluid around the great saphenous vein is crucial for the success of EMA; however, paradoxically, this is also the area where patients experience the most severe pain. The commonly used tumescent solution is a crystalline solution containing local anesthetics and adrenaline, which is acidic in nature and is the main reason for the 'sting' sensation during skin infiltration. A Cochrane review indicated that adjusting the pH of lidocaine solution by adding sodium bicarbonate significantly reduced pain during the skin infiltration process, as measured by the 10-centimeter Visual Analog Scale (VAS). Moreover, the temperature of the tumescent anesthetic solution also affects pain during the skin infiltration process, as noted by Bell et al. Alonso et al. found in a prospective randomized controlled trial that heating local anesthetic solutions to 37°C and 42°C can reduce pain, and heating adrenaline-containing local anesthetic solutions to near body temperature is also an effective method to alleviate local anesthetic pain. We hope to achieve better preoperative prevention and intraoperative management through an analysis of pain-related factors, thereby improving the patient's surgical experience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Hospital of Chengdu University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with primary VVs from December 2024 to December 2025 who were admitted to the hospital and underwent endovenous microwave ablation treatment for the main trunk of the saphenous vein

Description

Inclusion Criteria:

  1. Age≥ 18 years old, ≤ 90 years old;
  2. the patient's life expectancy is greater than 12 months;
  3. The clinical diagnosis is primary VVs, CEAP classification C2-C6, and the GSV segment needs to be treated, including pain, burning sensation, heaviness, fatigue, itchy skin, night cramps and other clinical symptoms;
  4. Doppler ultrasound confirmed that the diameter of GSV was greater than 3mm and less than 12mm when standing;
  5. Doppler ultrasound confirms that GSV is located in the saphenofascia or the distance between GSV and the skin surface is >1cm;
  6. endovenous microwave ablation treatment only for unilateral GSV walking area;
  7. The patient is willing to cooperate with the completion of the examination specified in the protocol.

Exclusion Criteria:

  1. GSV thrombosis, or combined with deep vein thrombosis, or previous history of deep vein thrombosis and pulmonary embolism;
  2. patients with recurrence after prior VVs-related surgery (C2r);
  3. the GSV trunk is severely distorted, and it is expected that the catheter will not be able to pass;
  4. Severe ischemia of the lower limbs, Ankle brachial pressure index (ABPI) < 0.8;
  5. Known allergy to the drugs and device materials involved in the study;
  6. Previously implanted with a pacemaker or defibrillator, and currently receiving regular anticoagulation therapy (such as warfarin, heparin);
  7. Pregnant or lactating females;
  8. Patients who are unable or unwilling to participate in the study;
  9. Participating in the research of other drugs or devices;
  10. Skin malignancies other than non-melanoma that are being treated;
  11. daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain caused by venous disease;
  12. The investigator judged that endovenous treatment was not suitable;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observation of Pain and Analysis of Related Factors During Microwave Ablation Treatment of Saphenous
Among 155 patients, our team measured the diameter of the great saphenous vein preoperatively according to the CEAP classification and ultrasound measurements. We performed endovenous microwave ablation of the great saphenous vein along with foam sclerotherapy and point stripping treatment. We documented the operating room temperature, puncture site, VAS scores during puncture and catheter placement, the amount of injected tumescent fluid, radiofrequency generator used, and data at the conclusion of the surgery. A descriptive analysis of intraoperative pain scores was conducted to evaluate the level of pain experienced during the surgery. A nonparametric test was utilized to analyze the relationship between preoperative and intraoperative factors and the level of pain experienced during the surgery.
Procedure: VAS scores of the puncture
All patients were evaluated by our team with CEAP grading and ultrasound measurements to record the diameter of the saphenous vein before surgery。We performed endovenous microwave ablation of the great saphenous vein along with foam sclerotherapy and point stripping treatment. We documented the operating room temperature, puncture site, VAS scores during puncture and catheter placement, the amount of injected tumescent fluid, radiofrequency generator used, and data at the conclusion of the surgery. A descriptive analysis of intraoperative pain scores was conducted to evaluate the level of pain experienced during the surgery. A nonparametric test was utilized to analyze the relationship between preoperative and intraoperative factors and the level of pain experienced during the surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Pain Score
Time Frame: during operation
We mainly record the VAS pain scores during local anesthetic injection, needle puncture, catheter placement, swollen anesthetic injection, microwave generator operation, and at the end of the surgery.
during operation
Basic data related to surgery
Time Frame: intraoperative
We also documented the patient's heart rate, blood pressure, oxygen saturation, along with the temperature of the operating room, location of puncture, number of incisions, and volume of injected swelling fluid, among others. These data are recorded to explore their correlation with the intraoperative VAS pain score.
intraoperative

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu University of Traditional Chinese Medicine

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

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November 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChengduUTCMvs7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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