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Breast CancerNCT03782896

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

An observational study of Breast Cancer and Chronic Post-Procedural Pain, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 70 years, women only
Conditions the study is for
Breast Cancer, Chronic Post-Procedural Pain
What is being tested?
acute postoperative pain
How many people
89 participants
Where
1 siteSouth Korea
Study dates
31 Dec 2018to 30 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • -undergoing breast conserving surgery + sentinel lymph node dissection

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

Other trials in 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.

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.

Read the 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.

Being tested
acute postoperative pain
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acute postoperative painOther

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

Study groups in NCT03782896
Study groupRoleWhat they receive
mastectomy groupAll patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
Receives: Other: acute postoperative pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. persistent pain

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

    Measured: postoperative 2 months

  2. acute postoperative pain

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

    Measured: postoperative 1 hour

Secondary outcomes (9)

  1. inhalation agent

    inhalation anesthetics use or total intravenous anesthesia

    Measured: intraoperative

  2. opioid consumption

    the amount of opioid

    Measured: intraoperative

  3. surgical anxiety level

    (0: not anxiety-100: extremely anxious)

    Measured: 1 day before surgery

  4. anticipate pain

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

    Measured: 1 day before surgery

  5. 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)

    Measured: 1 day before surgery

  6. surgery factor

    the incision size and the number of excision of lymph node

    Measured: intraoperative

  7. The surgical pleth index

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

    Measured: intraoperative

  8. The pain score of discharge

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

    Measured: on the 1 day of discharge

  9. the consumption of postoperative analgesia

    the consumption of postoperative analgesia during in-hospital day

    Measured: postoperative 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start31 Dec 2018
  3. Primary completion5 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03782896
Sponsor's protocol ID
SMC2018-09-029-003
Status last verified
Dec 2018
First submitted
19 Dec 2018
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23290256

  • 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.

    PubMed 30065342

  • 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.

    PubMed 19903919

  • 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.

    PubMed 23485992

  • 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.

    PubMed 26053994

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Chronic Post-Procedural Pain, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

persistent pain (time frame: postoperative 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03782896, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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