Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II

Breast Cancer Clinical Trial

Official title:

Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II: a Prospective Follow-up After a Prospective Double Blind Placebo-controlled Randomized Controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116048
• Other study ID #: GZA-ANE-PECS-02
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: February 2018
• Source: GZA Ziekenhuizen Campus Sint-Augustinus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. Post-procedural pain relief is known to diminish persistent pain. In this prospective follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients.

Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.

Description:

Breast cancer is the most common cancer in women. For breast cancer patients, surgery is the most effective therapeutic intervention. Up to two thirds of female patients undergoing breast cancer surgery develop chronic post-procedural pain. This can be best understood by the fact that chronic post-procedural pain is strongly associated with acute post-procedural pain and that even minimal breast surgery can result in significant post-procedural pain.

Regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes. In the prospective double blind placebo-controlled randomized controlled trial, the investigators found that the pectoral nerves (Pecs) block type II, as described by Blanco et al., provides reliable and effective post-procedural analgesia for patients undergoing breast surgery.

In this prospective follow-up, the investigators evaluate whether the Pecs II block is effective in reducing chronic post-procedural pain in female adult patients undergoing breast cancer surgery compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 24, 2018
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)

Exclusion Criteria:

• patient refusal

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Post-Procedural Pain

Intervention

Other:
• Chronic pain evaluation
Chronic pain assessment with study questionnaire

Locations

Country	Name	City	State
Belgium	GZA Sint Augustinus	Wilrijk	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
GZA Ziekenhuizen Campus Sint-Augustinus

Country where clinical trial is conducted

Belgium, 

References & Publications (11)

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. — View Citation

Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-44. doi: 10.1016/j.pain.2009.08.019. Review. — View Citation

El-Tamer MB, Ward BM, Schifftner T, Neumayer L, Khuri S, Henderson W. Morbidity and mortality following breast cancer surgery in women: national benchmarks for standards of care. Ann Surg. 2007 May;245(5):665-71. — View Citation

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. — 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

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. — View Citation

Mejdahl MK, Andersen KG, Gärtner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865. — 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

Wijayasinghe N, Andersen KG, Kehlet H. Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study. Pain Pract. 2017 Feb;17(2):185-191. doi: 10.1111/papr.12423. Epub 2016 Feb 9. — View Citation

Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic post- procedural pain evaluation through questionaire	Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block	1-3 years