Continuous Serrates Plane Block in Axillary Dissection

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992859
• Other study ID #: CIMPAX BREAST
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: June 13, 2020

Study information

• Verified date: June 2019
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: Federico bizzarri
• Phone: 3478351913
• Email: federicotommaso.bizzarri[@]ausl.re.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 13, 2020
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age > 18

• breast surgery

• informed consent

Exclusion Criteria:

• ASA >3

• allergy to local anesthetic

• opioid administration in the last month

• patient refusal

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Continuous serratus plane block
Peripheral nerve catheter placed by the surgeon at the end of surgery

Locations

Country	Name	City	State
Italy	Ausl-Irccs Reggio Emilia	Reggio Emilia	RE

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	A 70% reduction in morphine consumption in the continuous serratus plane block over control	12-48 hours
Secondary	persistent post-surgical pain: numerical rating scale	a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4	3-6 months