CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Ropivacaine +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04824599
NCT04824599N/ACompleted

Interpectoral and Pectoserratus Plane Block vs Local Anesthetic Infiltration for Partial Mastectomy - a Prospective Randomized Trial

Karlstad Central Hospital·interventional·Posted Apr 1, 2021·Updated Sep 7, 2023

In Brief

A clinical study evaluating PECS II, Local anesthetic infiltration, and 3 other interventions for Breast Neoplasm. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon. The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasm
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 1, 2021
Enrollment StartFeb 19, 2021
Primary CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.3 years ago

Interventions

PECS IIprocedure

Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.

Local anesthetic infiltrationprocedure

Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.

Subcutaneus local anesthetic infiltrationprocedure

Ropivacaine is administered by the surgeon at the end of surgery

Ropivacainedrug

Local anesthetic ropivacaine is administered in both study arms according to the study protocol

bk medical Flex Focus 500 Ultrasound Machinedevice

Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.