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Continuous Serrates Plane Block in Axillary Dissection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03992859
Enrollment
15
Registered
2019-06-20
Start date
2018-01-12
Completion date
2021-12-30
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

regional anesthesia

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREContinuous serratus plane block

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

Sponsors

Azienda USL Reggio Emilia - IRCCS
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age \> 18 * breast surgery * informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumption12-48 hoursA 70% reduction in morphine consumption in the continuous serratus plane block over control

Secondary

MeasureTime frameDescription
persistent post-surgical pain: numerical rating scale3-6 monthsa numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),\> 4

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026