Serratus plane block plus intravenous sedation as anesthetic technique during axillary dissection procedure.

Anesthesia

Regional Anesthesia Morbidity

Axillary Metastases

Nerve Block

Analgesia

Skin Cancer

Ultrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line.

Serratus plane block

Axillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes.

Axillary dissection

Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.

Intravenous sedation

Hospital do Câncer II - National Cancer Institute of Brazil (INCA - Brazil)

Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

Assessment of the Feasibility of Ultrasound Guided Serratus Plane Block Associated With Sedation as Anesthetic Technique in Axillary Dissection

Percentage of patients who needed conversion to general anesthesia. A percentage from 0 to 100%, where 0% means that no patient needs technique conversion to general anesthesia and 100% means that all patients need it.

The QLQ-C30 is composed of multi-item scales and single-item measures. These include:
A global health status / QoL scale
Five functional scales (Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning)
Three symptom scales (Fatigue, Nausea and vomiting, Pain)
Six single items (Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties) Each of the multi-item scales includes a different set of items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems . The scales are scored as described as described in EORTC QLQ-C30 Scoring Manual. 2001 EORTC, Brussels.

Quality of Recovery - 40 Item questionnaire
QoR-40 score is a score developed to estimate the quality of recovery after anesthesia. It consists of a 40-item questionnaire with items on a five- point Likert scale (for positive items, 1 'none of the time' to 5 'all of the time'; for negative items the scoring was reversed). It is scored as follows:
QoR-40 dimensions
Emotional state (9-45)
Physical comfort (12-60)
Psychological support (7-35)
Physical independence (5-25)
Pain (7-35) Global QoR-40 (40-200)

A five points Likert scale will be applied to the main surgeon responsible for the operation.
The surgeon will be asked to fill out a Likert 5 points scale to access his opinion about the quality of anesthesia (extremely satisfied, satisfied, not satisfied or dissatisfied, dissatisfied, extremely dissatisfied).

A five points Likert scale will be applied to the patient in the first postoperative day visit to access his opinion about the quality of the anesthesia (extremely satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, extremely dissatisfied).

Eleven point numeric pain rating scale (0 means no pain and 10 means worst possible pain).

All the anesthetics and analgesics used in intraoperative and postoperative period will be recorded. Doses will be recorded in database.

Number of lymph nodes extracted according to anatomopathological report.

Instituto Nacional de Cancer, Brazil

Sham PEMF Device: Inactive PEMF device, delivers no PMF

Sham PEMF Device

PEMF Device: The PEMF device we will use in this study is FDA approved for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.

PEMF Device

Total

Sex: Female, Male

Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).

Pain Level on Visual Analog Scale

Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.

Jackson Pratt (JP) Drain Output

No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.

Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF

No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.

Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF

No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.

Lymphedema

No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.

Narcotic Pain Medications

Overall Study

Christine Rohde

Shoulder Symptoms After Lymph Node Dissection

The PEMF device we will use in this study is FDA approved for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.

lymphedema/vómito

Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection

Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity

Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?

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