Pecs II Block as Alternative for Paravertebral Block in Modified Radical Mastectomy

NCT ID: NCT02839083

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-31

Brief Summary

Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.

Detailed Description

Various modalities have been used for perioperative pain management in relevance to breast surgery. Thoracic epidural and paravertebral blocks (PVB) became the gold standard techniques to achieve this goal. However, both techniques may be associated with devastating complications such as spinal cord injury, total spinal anesthesia, inadvertent intravascular injection and pneumothorax.

On the other hand, the advancement of ultrasound (US) technology and our ability to visualize the pleura and other structures in and around the paravertebral space has increased interest in performing thoracic paravertebral blocks guided by US.

"Pecs" block is a less invasive procedure involving US guided interfascial injections has been suggested as potential alternative analgesic technique. The Pecs I block was initially described by Blanco for minor breast surgery. A year later, on 2012, he described a Pecs II block or "modified Pecs block" for breast surgery involving the axilla.

The Pecs I block targets the medial pectoral nerve (MPN) from C8 and T1 and the lateral pectoral nerve (LPN) from C5, C6, and C7. These nerves arise from the medial and lateral cords of the brachial plexus, respectively, and innervate the pectoralis muscles.

The Pecs II block targets the T2-6 intercostal nerves, the long thoracic nerve which supplies the serratus anterior, and the thoracodorsal nerve which supplies the latissimus dorsi. Potential complications include accidental intravascular injection and pneumothorax.

The easily identifiable landmarks allow this block to provide a simple alternative to paravertebral and neuraxial blocks for breast surgery. The block produces excellent analgesia and can be used as a rescue block in cases with patchy or ineffective paravertebral or epidural block.

Conditions

Modified Radical Mastectomy

Study Design

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

Study Groups

Thoracic Paravertebral group

Ultrasound guided thoracic paravertebral block

Group Type: PLACEBO_COMPARATOR

Thoracic Paravertebral group

Intervention Type: OTHER

Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml

Pecs II group

Ultrasound guided Pecs II block

Group Type: ACTIVE_COMPARATOR

Pecs II group

Intervention Type: OTHER

Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml

Interventions

Thoracic Paravertebral group

Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml

Intervention Type: OTHER

Pecs II group

Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• American Association for Anesthesiologists physical status I or II
• Body mass index > 40 kg/m2

Exclusion Criteria

• Patient refusal
• Severe or uncompensated cardiovascular disease.
• Significant renal disease.
• Significant hepatic disease.
• Significant endocrinal disease.
• Pregnancy.
• Postpartum period.
• Lactating females.
• Allergy to any of the study medication.
• Coagulation disorders.
• Infection at the site of needle insertion.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abd-Elaziz Metawa, MD

Role: STUDY_CHAIR

Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Locations

Mansoura university

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MD ∕ 153

Identifier Type: -

Identifier Source: org_study_id