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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Chronic Post-Procedural Pain
• Intervention / Treatment: Other: acute postoperative pain

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.

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

the 20-70 year old patients who undergoing breast conserving surgery + sentinel lymph node dissection at samsung medical center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mastectomy group; All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)	Other: acute postoperative pain; All patients assessed postoperative pain score in the recovery room and postoperative 2 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
persistent pain	persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)	postoperative 2 months
acute postoperative pain	acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)	postoperative 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhalation agent	inhalation anesthetics use or total intravenous anesthesia	intraoperative
opioid consumption	the amount of opioid	intraoperative
surgical anxiety level	(0: not anxiety-100: extremely anxious)	1 day before surgery
anticipate pain	(0: no pain-100: a bad as you can imagine)	1 day before surgery
anticipated pain medication need	(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)	1 day before surgery
surgery factor	the incision size and the number of excision of lymph node	intraoperative
The surgical pleth index	the highest surgical pleth index score in time of start anesthesia and ene of anesthesia	intraoperative
The pain score of discharge	Numeric rating pain score (NSR: no pain=1, worst pain=10)	on the 1 day of discharge
the consumption of postoperative analgesia	the consumption of postoperative analgesia during in-hospital day	postoperative 72 hours

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
• Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.
• Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.
• Cui L, Fan P, Qiu C, Hong Y. Single institution analysis of incidence and risk factors for post-mastectomy pain syndrome. Sci Rep. 2018 Jul 31;8(1):11494. doi: 10.1038/s41598-018-29946-x.
• Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Pain, Procedural
• Other Study ID Numbers: SMC2018-09-029-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No