The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782896
• Other study ID #: SMC2018-09-029-003
• Status: Completed
• Start date: December 31, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 30, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Post-Procedural Pain
• Pain, Procedural

Intervention

Other:
• acute postoperative pain
All patients assessed postoperative pain score in the recovery room and postoperative 2 month

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (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. — View Citation

Gärtner 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. — View Citation

Lefebvre-Kuntz D, Dualé C, Albi-Feldzer A, Nougarède 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. — View Citation

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. — View Citation

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):660-8. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistent pain	persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)	postoperative 2 months
Primary	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	inhalation agent	inhalation anesthetics use or total intravenous anesthesia	intraoperative
Secondary	opioid consumption	the amount of opioid	intraoperative
Secondary	surgical anxiety level	(0: not anxiety-100: extremely anxious)	1 day before surgery
Secondary	anticipate pain	(0: no pain-100: a bad as you can imagine)	1 day before surgery
Secondary	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
Secondary	surgery factor	the incision size and the number of excision of lymph node	intraoperative
Secondary	The surgical pleth index	the highest surgical pleth index score in time of start anesthesia and ene of anesthesia	intraoperative
Secondary	The pain score of discharge	Numeric rating pain score (NSR: no pain=1, worst pain=10)	on the 1 day of discharge
Secondary	the consumption of postoperative analgesia	the consumption of postoperative analgesia during in-hospital day	postoperative 72 hours