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Status unknownNCT02839083Updated Jul 20, 2016

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

An interventional study of Thoracic Paravertebral group and Pecs II group in Modified Radical Mastectomy, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Modified Radical Mastectomy
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Thoracic Paravertebral group

    Ultrasound guided thoracic paravertebral block

    Other: Thoracic Paravertebral group

  • Active comparator
    Pecs II group

    Ultrasound guided Pecs II block

    Other: Pecs II group

Interventions

  • OtherThoracic Paravertebral group

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

  • OtherPecs II group

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

06

What researchers measure

Primary outcomes

  1. Pain scores

    Pain visual analog scale is used to assess the severity of postoperative pain

    Time frame: For 24 hours after surgery

Secondary outcomes

  1. 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

    Time frame: for 12 hours after surgery

  2. Cumulative postoperative meperidine consumption

    Cumulative consumption of rescue meperidine analgesic for 24 hours

    Time frame: for 48 hours after surgery

07

Study locations

1 site
  • Mansoura university
    Mansoura, DK 050, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02839083
Lead sponsor
Mansoura University
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Apr 2015
Primary completion
Nov 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 20, 2016

Study contacts

Abd-Elaziz Metawa, MD
study chair · Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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