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NCT Number: NCT03782896

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chronic Post-Procedural Pain Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acute postoperative pain

Other

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

Primary outcomes

  1. persistent pain

    Time frame: postoperative 2 months

    persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)

  2. acute postoperative pain

    Time frame: postoperative 1 hour

    acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)

Secondary outcomes

  1. inhalation agent

    Time frame: intraoperative

    inhalation anesthetics use or total intravenous anesthesia

  2. opioid consumption

    Time frame: intraoperative

    the amount of opioid

  3. surgical anxiety level

    Time frame: 1 day before surgery

    (0: not anxiety-100: extremely anxious)

  4. anticipate pain

    Time frame: 1 day before surgery

    (0: no pain-100: a bad as you can imagine)

  5. anticipated pain medication need

    Time frame: 1 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)

  6. surgery factor

    Time frame: intraoperative

    the incision size and the number of excision of lymph node

  7. The surgical pleth index

    Time frame: intraoperative

    the highest surgical pleth index score in time of start anesthesia and ene of anesthesia

  8. The pain score of discharge

    Time frame: on the 1 day of discharge

    Numeric rating pain score (NSR: no pain=1, worst pain=10)

  9. the consumption of postoperative analgesia

    Time frame: postoperative 72 hours

    the consumption of postoperative analgesia during in-hospital day

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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