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

Modified Radical Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02839083
• Other study ID #: MD / 153
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 16, 2016
• Last updated: July 16, 2016
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Educaion
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Modified Radical Mastectomy

Intervention

Other:
• Thoracic Paravertebral group
Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml
• Pecs II group
Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Pain visual analog scale is used to assess the severity of postoperative pain	For 24 hours after surgery	No
Secondary	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	No
Secondary	Cumulative postoperative meperidine consumption	Cumulative consumption of rescue meperidine analgesic for 24 hours	for 48 hours after surgery	No