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Breast NeoplasmsEarly Phase 1PNBCPNCT02719795

Pectoral Nerves Blocks for Chronic Pain

A Early Phase 1 study testing Ropivacaine and Normal saline in people with Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce chronic pain at 3 months after modified radical mastectomy（MRM）surgery. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Ropivacaine and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteChina
Study dates
Apr 2016to Feb 2019
Phase
Early Phase 1
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 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Modified radical mastectomy
  • American Society of Anesthesiologists physical status 1-3
  • BMI 18-35 kg/m2

Who cannot join

  • Declining to give written informed consent；
  • Uncontrolled hypertension；
  • Allergy to local anesthetics；
  • Pregnancy；
  • Alcohol or drug abuse；
  • Prior breast surgery except for diagnostic biopsies；
Show all 11Show fewer
  • Contraindication to the use of regional anesthesia；
  • History of chronic pain or psychiatric disorder and pregnant patients；
  • Consumption of NSAID, cyclooxygenase-2 inhibitors or paracetamol within 24 hours before the investigation；
  • Infection at the needle site.
  • Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Trial locations and contacts

1 site in 1 country.

Tan Jing, M.D；PhD contact

0086-18302982890

18991232757@189.cn

China1 site, 1 recruiting

  • First Affiliated Hosipital of Xi'an Jiaotong Univercity

    Xi'an, Shaanxi, 710061

    Tan Jing, M.D；PhD, 0086-18302982890, 18991232757@189.cn

    Recruiting

Other trials in China

About this study

Official title: Pectoral Nerves Blocks and Their Effect on Chronic Pain After Breast Cancer Surgery

The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce chronic pain at 3 months after modified radical mastectomy（MRM）surgery.

Read the detailed description

One hundred and forty adult female participants scheduled for elective unilateral modified radical mastectomy under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=70) or general anesthesia alone (control group, n=70).

After arrived in the operating room，the participants in the control group are accepted the general anesthesia.Whereas，after anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block and a 15 minute observation time prior before the start of the operation.

Pecs block technology： A broadband (5-12 hertz) linear array probe of Sonosite Edge portable ultrasound system (Sonosite Inc,Bethel,Washington) is used, with an imaging depth of 4 to 6 cm. After cleaning the infraclavicular and axillary regions with chlorhexidine, the probe is placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the skin puncture point is infiltrated with 2% lignocaine, then the block is performed by using a 20-gauge Tuohy needle. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.35% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib below the serratus anterior muscle with the intent of spreading injectate to the axilla.

Being tested
Ropivacaine, Normal saline
Keywords
Breast Neoplasms, Nerve block, Anesthesia
Medical subject headings
Breast Neoplasms

What participants receive

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

  • RopivacaineDrug

    Also called Naropin

    Local injection of local anesthetic into the fascial spaces

  • Normal salineDrug

    Also called Stroke-physiological saline solution

    Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.

Study groups in NCT02719795
Study groupRoleWhat they receive
RopivacaineExperimentalRopivacaine hydrochloride injection； Generic name：Naropin； Dosage form：Liquid、Injectable formulation； Dosage：105mg；30ml； Frequency：Once.
Receives: Drug: Ropivacaine
Normal salinePlacebo comparatorMedical Normal saline Generic name：Normal saline； Dosage form：Liquid、Injectable formulation； Dosage：30ml； Frequency：Once.
Receives: Drug: Normal saline

What is being measured

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

  1. The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery

    An anesthesiologist interviews the patients by phone to determine the postoperative pain at 3 months after surgery. Chronic pain is defined as pain in the surgical area or the ipsilateral arm, present at least 4 days a week, with an intensity of 3 or more on the verbal rating scale（0=no pain to 10=worst imaginable pain),described as a typical neuropathic pain consisting of burning pain, shooting pain, pain evoked by pressure, and deep blunt pain.

    Measured: 3 months after modified radical mastectomy surgery

Secondary outcomes (6)

  1. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 0 hour postoperative.

    Measured: 0 hour postoperative

  2. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 4 hours postoperative.

    Measured: 4 hours postoperative

  3. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 12 hours postoperative.

    Measured: 12 hours postoperative

  4. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 24 hours postoperative.

    Measured: 24 hours postoperative

  5. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 48 hours postoperative.

    Measured: 48 hours postoperative

  6. Postoperative Numerical Rating scale (NRS) score for pain

    Pain scores（0-10）during rest and cough based on measurement at 72 hours postoperative.

    Measured: 72 hours postoperative

Timeline

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

  1. First posted25 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719795
Sponsor's protocol ID
XJTU1AF-CRS-2016-003
Acronym
PNBCP
Status last verified
Apr 2016
First submitted
15 Mar 2016
Last updated
17 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Amaya F, Hosokawa T, Okamoto A, Matsuda M, Yamaguchi Y, Yamakita S, Taguchi T, Sawa T. Can acute pain treatment reduce postsurgical comorbidity after breast cancer surgery? A literature review. Biomed Res Int. 2015;2015:641508. doi: 10.1155/2015/641508. Epub 2015 Oct 1.

    PubMed 26495309

  • Oeffinger KC, Fontham ET, Etzioni R, Herzig A, Michaelson JS, Shih YC, Walter LC, Church TR, Flowers CR, LaMonte SJ, Wolf AM, DeSantis C, Lortet-Tieulent J, Andrews K, Manassaram-Baptiste D, Saslow D, Smith RA, Brawley OW, Wender R; American Cancer Society. Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA. 2015 Oct 20;314(15):1599-614. doi: 10.1001/jama.2015.12783.

    PubMed 26501536

  • Bolin ED, Harvey NR, Wilson SH. Regional anesthesia for breast surgery: Techniques and benefits. Current Anesthesiology Reports 2015;5:217-224.

  • Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

    PubMed 25376971

  • Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.

    PubMed 16942948

  • 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

  • Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.

    PubMed 12855309

  • Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

    PubMed 21831090

  • Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

    PubMed 22939099

  • Perez MF, Miguel JG, de la Torre PA. A new approach to pectoralis block. Anaesthesia. 2013 Apr;68(4):430. doi: 10.1111/anae.12186. No abstract available.

    PubMed 23488849

  • Perez MF, Duany O, de la Torre PA. Redefining PECS Blocks for Postmastectomy Analgesia. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):729-30. doi: 10.1097/AAP.0000000000000243. No abstract available.

    PubMed 26488081

  • Ibarra MM, S-Carralero GC, Vicente GU, Cuartero del Pozo A, Lopez Rincon R, Fajardo del Castillo MJ. [Chronic postoperative pain after general anesthesia with or without a single-dose preincisional paravertebral nerve block in radical breast cancer surgery]. Rev Esp Anestesiol Reanim. 2011 May;58(5):290-4. doi: 10.1016/s0034-9356(11)70064-0. Spanish.

    PubMed 21692253

  • Karmakar MK, Samy W, Li JW, Lee A, Chan WC, Chen PP, Ho AM. Thoracic paravertebral block and its effects on chronic pain and health-related quality of life after modified radical mastectomy. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):289-98. doi: 10.1097/AAP.0000000000000113.

    PubMed 24956453

  • Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

    PubMed 18682712

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ropivacaine and Normal saline in people with Breast Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Feb 2017. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Tan Jing, M.D；PhD (0086-18302982890, 18991232757@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of chronic postoperative pain for 3 months after modified radical mastectomy surgery (time frame: 3 months after modified radical mastectomy surgery). 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 NCT02719795, which also lists 14 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 17 Feb 2017.

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Pectoral Nerves Blocks for Chronic Pain (NCT02719795) | AzTrials