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The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03782896
Enrollment
89
Registered
2018-12-20
Start date
2018-12-31
Completion date
2019-12-30
Last updated
2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chronic Post-Procedural Pain

Brief summary

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain. This study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

Detailed description

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain. There were reports of no association with anesthesia in the area of anesthesia to the high pain control requirement in the postoperative recovery room, 24 hours of high pain medication, use of inhalation agent, and a high dosage of remifentanil. However, an anesthesia-related study was either a retrospective study or anesthetic was injected with more than a clinical dose in order to make the difference following methods. In this study, bispectral index is used to maintain anesthesia depth. In addition, the commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to assess the nociception-antinociception balance. Displays the automatically calculated values of SPI=100-(0.3\*heartbeat interval + 0.7\*photoplethysmographic pulse wave ampule) using a waveform with peripheral oxygen saturation. Through this process, patients want to objectify the amount of anesthetic agent used during surgery. And all patients are inserted the laryngeal mask airway. This study would try find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges. The investigators hypothesize that patients who suffered severe acute postoperative pain, regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy pain.

Interventions

OTHERacute postoperative pain

All patients assessed postoperative pain score in the recovery room and postoperative 2 month

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

-undergoing breast conserving surgery + sentinel lymph node dissection

Exclusion criteria

* cardiac arrythmia * allergic history for drugs * renal failure (Cr\> 1.5 mg/dl) * performing axillary lymph node dissection or Total mastectomy * difficult airway and failed to place laryngeal mask airway properly

Design outcomes

Primary

MeasureTime frameDescription
persistent painpostoperative 2 monthspersistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
acute postoperative painpostoperative 1 houracute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)

Secondary

MeasureTime frameDescription
surgical anxiety level1 day before surgery(0: not anxiety-100: extremely anxious)
anticipate pain1 day before surgery(0: no pain-100: a bad as you can imagine)
anticipated pain medication need1 day before surgery(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)
inhalation agentintraoperativeinhalation anesthetics use or total intravenous anesthesia
The surgical pleth indexintraoperativethe highest surgical pleth index score in time of start anesthesia and ene of anesthesia
The pain score of dischargeon the 1 day of dischargeNumeric rating pain score (NSR: no pain=1, worst pain=10)
the consumption of postoperative analgesiapostoperative 72 hoursthe consumption of postoperative analgesia during in-hospital day
surgery factorintraoperativethe incision size and the number of excision of lymph node
opioid consumptionintraoperativethe amount of opioid

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026