Pectoral Nerves Blocks for Chronic Pain

Breast Neoplasms Clinical Trial

— PNBCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02719795
• Other study ID #: XJTU1AF-CRS-2016-003
• Status: Recruiting
• Phase: Early Phase 1
• First received: March 15, 2016
• Last updated: February 15, 2017
• Start date: April 2016
• Est. completion date: February 2019

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Tan Jing, M.D;PhD
• Phone: 0086-18302982890
• Email: 18991232757[@]189.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Modified radical mastectomy

• American Society of Anesthesiologists physical status 1-3

• BMI 18-35 kg/m2

Exclusion Criteria:

• Declining to give written informed consent;

• Uncontrolled hypertension;

• Allergy to local anesthetics;

• Pregnancy;

• Alcohol or drug abuse;

• Prior breast surgery except for diagnostic biopsies;

• 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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Chronic Pain

Intervention

Drug:
• Ropivacaine
Local injection of local anesthetic into the fascial spaces
• Normal saline
Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.

Locations

Country	Name	City	State
China	First Affiliated Hosipital of Xi'an Jiaotong Univercity	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (14)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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) — View Citation

Ibarra MM, S-Carralero GC, Vicente GU, Cuartero del Pozo A, López Rincón 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 surger — View Citation

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. Review. — View Citation

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 — View Citation

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 Societ — View Citation

Pérez 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. — View Citation

Pérez MF, Miguel JG, de la Torre PA. A new approach to pectoralis block. Anaesthesia. 2013 Apr;68(4):430. doi: 10.1111/anae.12186. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after modified radical mastectomy surgery
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 0 hour postoperative.	0 hour postoperative
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 4 hours postoperative.	4 hours postoperative
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 12 hours postoperative.	12 hours postoperative
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 24 hours postoperative.	24 hours postoperative
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 48 hours postoperative.	48 hours postoperative
Secondary	Postoperative Numerical Rating scale (NRS) score for pain	Pain scores(0-10)during rest and cough based on measurement at 72 hours postoperative.	72 hours postoperative