search
Back to results

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

Primary Purpose

Chronic Post-Procedural Pain, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Chronic pain evaluation
Sponsored by
GZA Ziekenhuizen Campus Sint-Augustinus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Post-Procedural Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • GZA Sint Augustinus

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pecs group (study group)

Control group (placebo group)

Arm Description

Chronic pain assessment with study questionnaire

Chronic pain assessment with study questionnaire

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 3, 2017
Last Updated
February 13, 2019
Sponsor
GZA Ziekenhuizen Campus Sint-Augustinus
search

1. Study Identification

Unique Protocol Identification Number
NCT03116048
Brief Title
Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
April 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GZA Ziekenhuizen Campus Sint-Augustinus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-Procedural Pain, Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pecs group (study group)
Arm Type
Other
Arm Description
Chronic pain assessment with study questionnaire
Arm Title
Control group (placebo group)
Arm Type
Other
Arm Description
Chronic pain assessment with study questionnaire
Intervention Type
Other
Intervention Name(s)
Chronic pain evaluation
Intervention Description
Chronic pain assessment with study questionnaire
Primary Outcome Measure Information:
Title
Chronic post- procedural pain evaluation through questionaire
Description
Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block
Time Frame
1-3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Van Houwe, MD
Organizational Affiliation
GZA Ziekenhuizen Campus Sint-Augustinus
Official's Role
Study Director
Facility Information:
Facility Name
GZA Sint Augustinus
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25220842
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.
Results Reference
background
PubMed Identifier
17457156
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. doi: 10.1097/01.sla.0000245833.48399.9a.
Results Reference
background
PubMed Identifier
16942948
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. doi: 10.1016/j.jpain.2006.02.007.
Results Reference
background
PubMed Identifier
23580693
Citation
Mejdahl MK, Andersen KG, Gartner 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.
Results Reference
background
PubMed Identifier
16698416
Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Results Reference
background
PubMed Identifier
10825328
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. doi: 10.1097/00000539-200006000-00026.
Results Reference
background
PubMed Identifier
21704871
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.
Results Reference
background
PubMed Identifier
22939099
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. Epub 2012 Aug 29.
Results Reference
background
PubMed Identifier
19903919
Citation
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. Erratum In: JAMA. 2012 Nov 21;308(19):1973.
Results Reference
background
PubMed Identifier
19836888
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):238-244. doi: 10.1016/j.pain.2009.08.019.
Results Reference
background
PubMed Identifier
26857336
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs