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OpenTrials
Completed

NCT Number: NCT03992859

Continuous Serrates Plane Block in Axillary Dissection

Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ausl-Irccs Reggio Emilia

Reggio Emilia, RE, 42120, Italy

About this study

84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age > 18
  • breast surgery
  • informed consent

Exclusion criteria

  • ASA >3
  • allergy to local anesthetic
  • opioid administration in the last month
  • patient refusal

Treatment and study plan

Continuous serratus plane block

Procedure

Peripheral nerve catheter placed by the surgeon at the end of surgery

Primary outcomes

  1. Morphine consumption

    Time frame: 12-48 hours

    A 70% reduction in morphine consumption in the continuous serratus plane block over control

Secondary outcomes

  1. persistent post-surgical pain: numerical rating scale

    Time frame: 3-6 months

    a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Continuous Serratus Plane Block Added to PECS II vs PECS II Alone for Post Operative Analgesia After Axillary Dissection in Breast Cancer Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jun 20, 2019
Registry last updated
Jun 25, 2025

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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