Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial

NCT ID: NCT05590559

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-12-31

Brief Summary

The objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction.

Detailed Description

n breast cancer treatment, surgery plays a central role in combination with chemotherapy, radiation and immunotherapy. Surgery may vary from conservative breast sparing interventions to large radical mastectomies with axillary lymph node dissection that require reconstructive (prosthetic) surgery. In many instances, reconstruction is not performed immediately, but immediate reconstruction is possible and offers many advantages to patients.

The Antoni van Leeuwenhoek hospital performs a large proportion (77%) of mastectomies with immediate reconstruction in the Netherlands. The combination of mastectomy with immediate reconstruction in one operation offers an extra challenge with regards to pain control. Post-operative pain is often treated with opioids, which has systemic side effects (nausea and vomiting). Opioids also inhibit cell-mediated immunity, which is a principal defense against cancer. Regional anesthetic techniques are often performed to reduce opioid consumption and enhance postoperative recovery. The current standard for regional anesthesia for breast surgery is the paravertebral block (PVB). This technique has the potential for severe complications such as epidural hematoma, hemo- or pneumothorax. The erector spinae plane block (ESP) was first described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, the ESP block has relatively few contraindications and has therefore been suggested as an alternative to PVB when contra-indications, such as a bleeding diathesis, are present.Multiple studies have shown a decrease in opioid consumption in patients undergoing mastectomy, when ESP was compared to placebo. ESP has also been shown to be non-inferior to PVB for pain relief in patients undergoing thoracotomy. To date, only two studies have compared ESP to PVB for breast surgery, with conflicting results. In this study, we would like to investigate whether ESP can be considered non-inferior to PVB with regards to pain relief and use of opioids.

Conditions

Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

paravertebral block

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Opiates

Ultrasound-guided erector spinae plane block

Group Type: EXPERIMENTAL

Ultrasound-guided erector spinae plane block

Intervention Type: OTHER

PVB

Interventions

Morphine

Opiates

Intervention Type: DRUG

Ultrasound-guided erector spinae plane block

PVB

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients (18 years of age or older)
• ASA I-III
• Patients scheduled for elective unilateral mastectomy followed by direct reconstruction
• Ability to give written and oral informed consent

Exclusion Criteria

• Patient refusal
• Non-elective surgery
• Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease )
• Allergy to amide-linked local anesthetics
• Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block)
• Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury
• Known psychiatric disorder
• Chronic pain patients or patients already using opioids pre-operatively
• Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NKI-AvL

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sandra Broens, PhD

Role: CONTACT

s.broens@nki.nl

+31(0)205122506

Facility Contacts

Sandra Broens

Role: primary

s.broens@nki.nl

+31205122506

Other Identifiers

N20ESP

Identifier Type: -

Identifier Source: org_study_id