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

Thoracic Paravertebral Block Versus Pecs II Block for Perioperative Analgesia in Modified Radical Mastectomy

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.

Study Overview

• Status: Unknown
• Conditions: Modified Radical Mastectomy
• Intervention / Treatment: Other: Thoracic Paravertebral group; Other: Pecs II group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Thoracic Paravertebral group; Ultrasound guided thoracic paravertebral block	Other: Thoracic Paravertebral group; Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml
Active Comparator: Pecs II group; Ultrasound guided Pecs II block	Other: Pecs II group; Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain visual analog scale is used to assess the severity of postoperative pain	For 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	period from completion of the block to time of administration of the first rescue analgesic for 12 hour after performing the block	for 12 hours after surgery
Cumulative postoperative meperidine consumption	Cumulative consumption of rescue meperidine analgesic for 24 hours	for 48 hours after surgery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Abd-Elaziz Metawa, MD, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 16, 2016
• First Submitted That Met QC Criteria: July 16, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 16, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MD ∕ 153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED