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

Not Applicable

Completed

• Conditions: Breast Cancer; Chronic Post-Procedural Pain
• Interventions: Other: Chronic pain evaluation

• Registration Number: NCT03116048
• Lead Sponsor: GZA Ziekenhuizen Campus Sint-Augustinus

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.

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2017-05-02
• Primary Completion: 2017-06-12
• Status Verified: 2018-02
• Study Completion: 2018-04-24
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecs group (study group)	Chronic pain evaluation	Chronic pain assessment with study questionnaire
Control group (placebo group)	Chronic pain evaluation	Chronic pain assessment with study questionnaire

Primary Outcome Measures

Name	Time	Method
Chronic post- procedural pain evaluation through questionaire	1-3 years	Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block

Trial Locations

Locations (1)

GZA Sint Augustinus; 🇧🇪 Wilrijk, Antwerpen, Belgium