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Completed

NCT Number: NCT02865265

Pecs II Block and PaB Could be an Alternative in Breast Surgery

The association between ultrasound-guided Pecs II block and parasternal block can represent a valid alternative in the management of acute and postoperative pain syndrome after quadrantectomy with or without axillary dissection.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

About this study

The combination of Pecs II block and PaB provides good management of postoperative pain and can be considered a viable alternative to common anesthetic procedures performed for breast cancer surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years of age;
  • American Society of Anesthesiologists (ASA) physical status I-III,
  • patients scheduled for quadrantectomy with or without axillary dissection

Exclusion criteria

  • pregnancy;
  • body mass index (BMI) >35;
  • allergy to local anesthetics;
  • skeletal or muscle abnormalities of the chest wall;
  • presence of primary or secondary neurological diseases;
  • presence of psychiatric diseases;
  • history of chronic pain or neuropathic disorders;
  • history of drug abuse;
  • state of sepsis;
  • infection
  • tumors of the skin on the chest;
  • primary;
  • secondary coagulopathies

Treatment and study plan

Pecs II and parasternal blocks

Procedure

Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected.

An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib.

Primary outcomes

  1. Pain

    Time frame: Pain was recorded at 24 months after surgery

    Pain has been evaluate with visual analogue scale (VAS) at 24 months after surgery

Secondary outcomes

  1. Neuropathic postoperative disturbances

    Time frame: Neuropathic postoperative disturbances were recorded at 24 months after surgery

    Neuropathic postoperative disturbances were examined using the von Frey hair test (neuropathic disturbances: present/not present) at 24 months

  2. Patient satisfaction

    Time frame: Patient satisfaction was evaluated at 1 day after surgery

    Patient satisfaction with regard to the anesthetic procedure was assessed using a five-step satisfaction scale (not at all/slightly/somewhat/very/extremely satisfied).

  3. Woud healing

    Time frame: Wound healing was assessed at 24 months after surgery

    Wound healing was assessed using a three-step scale (unacceptable/acceptable/excellent healing) in accordance with the surgeon's opinion.

Sponsors and collaborators

Lead sponsor

Emiliano Petrucci

Other

Registry information

Official study title

Association Between Ultrasound-guided Pecs II Block and Parasternal Block May Represent a Valid Alternative for the Management of Acute and Postoperative Pain Syndrome in Breast Cancer Surgery: a Retrospective Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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