Phase 4
Completed N=66
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Pain, Post-operative
Source: ClinicalTrials.gov NCT03154658 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Opioid Consumption — 113.5; 147 milligrams oral morphine equivalent
◆ Published Evidence
Established
60citations · ~12 / year
Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing mastectomy: A randomized prospective trial.
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.
Linked Publications
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Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing mastectomy: A randomized prospective trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03154658) and the linked publication. 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. Informational only — not medical advice.