Phase 4 N=66 Randomized Single-blind Treatment

Serratus Anterior Plane Block in Patients Undergoing Mastectomy

Pain, Post-operative

Bottom Line

View on ClinicalTrials.gov: NCT03154658 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Opioid Consumption — 113.5; 147 milligrams oral morphine equivalent

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ropivacaine 0.35% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Opioid Consumption	113.5; 147	—
SECONDARY Maximum Post-operative Pain Score	5.2; 5.9	—
SECONDARY Patient Satisfaction Scale	3.62; 3.24	—
SECONDARY Number of Participants With Nausea/Vomiting	14; 15	—
SECONDARY Length of Stay	2; 2	—
SECONDARY Sleep Duration Night of Postoperative Day 0	315; 276	—
SECONDARY Block Performance Time	8; 7.5	—

Summary

This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

Eligibility Criteria

Inclusion Criteria

Adult patients 18 years or older
Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

Exclusion Criteria

Any known sensory deficit of the anterolateral chest wall.
Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
Pregnancy
American Society of Anesthesiology classification greater than 3
Allergy to amide local anesthetic medications
Chronic pain conditions
Preoperative opioid use greater than 20 oral morphine equivalents per day
Any coagulation abnormality which would be a contraindication for block placement
Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
Body mass index >50
Incarceration
Inability to understand study procedures including inability to understand the English language
Inability to provide adequate informed consent
Refusal to participate in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03154658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.