The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery
- Conditions
- Chronic Post-Procedural PainBreast Cancer
- Interventions
- Other: acute postoperative pain
- Registration Number
- NCT03782896
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 89
-undergoing breast conserving surgery + sentinel lymph node dissection
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description mastectomy group acute postoperative pain All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
- Primary Outcome Measures
Name Time Method persistent pain postoperative 2 months persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
acute postoperative pain postoperative 1 hour acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)
- Secondary Outcome Measures
Name Time Method the consumption of postoperative analgesia postoperative 72 hours the consumption of postoperative analgesia during in-hospital day
surgical anxiety level 1 day before surgery (0: not anxiety-100: extremely anxious)
surgery factor intraoperative the incision size and the number of excision of lymph node
The surgical pleth index intraoperative the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
anticipated pain medication need 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)
The pain score of discharge on the 1 day of discharge Numeric rating pain score (NSR: no pain=1, worst pain=10)
opioid consumption intraoperative the amount of opioid
anticipate pain 1 day before surgery (0: no pain-100: a bad as you can imagine)
inhalation agent intraoperative inhalation anesthetics use or total intravenous anesthesia
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of