Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Primary Purpose
Pain, Post-operative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.35%
Sponsored by

About this trial
This is an interventional treatment trial for Pain, Post-operative
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
Sites / Locations
- University of Texas Southwestern Medical Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sub-serratus regional block
Supra-serratus regional block
Arm Description
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.
Outcomes
Primary Outcome Measures
Opioid Consumption
Measures number of milligrams morphine equivalents each subject receives
Secondary Outcome Measures
Maximum Post-operative Pain Score
Measures the change in pain scores on a 0-10 Numeric Rating Scale where 0 is no pain and 10 is the maximum pain.
Patient Satisfaction Scale
Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).
Number of Participants With Nausea/Vomiting
Measures the type and frequency of anti-emetics subjects receive
Length of Stay
Measures total number of days subject is hospitalized, including day of surgery
Sleep Duration Night of Postoperative Day 0
Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1
Block Performance Time
Measures total time for block to take effect
Full Information
NCT ID
NCT03154658
First Posted
May 3, 2017
Last Updated
February 24, 2021
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03154658
Brief Title
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
Official Title
Serratus Anterior Plane Block: Sub-Serratus vs Supra-Serratus Plane Block for Pain Control in Patients Undergoing Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Subjects will be randomized to one of two groups: the supra-serratus anterior plane block (depositing local anesthetic superficial to the serratus anterior muscle) or the sub-serratus anterior plane block (depositing local anesthetic deep to the serratus anterior muscle). Randomization will be performed using a computer generated randomization program. The results of the randomization will be revealed to the physician performing the block just prior to its performance. The site of the block will be marked and a safety timeout will be performed with the block nurse, regional anesthesiologist, and patient present and participating.
Once the above is completed, patients will receive a pre-operative ultrasound-guided single-injection serratus anterior plane block using either the supra-serratus or sub-serratus techniques according to their randomization. The block nurse will record the time when the timeout is performed, the "needle insertion" time when the block needle enters the skin, and the "block complete" time when the needle exits the skin. If the block is bilateral, the block nurse will record the time when the timeout is performed, then will record two sets of "needle in" times and "needle out" times, one for each side. In the case of a bilateral block, the same method of serratus anterior plane block will be utilized for both sides.
After the block, the patient will proceed to surgery. The operating room anesthesia team will be notified that the patient received a serratus anterior plane block. An appropriate multimodal general anesthetic will be employed at the operating room anesthesiologist's discretion. Upon completion of the surgery and emergence from general anesthesia, the patient will be seen by study personnel in the Post Anesthesia Care Unit and pain will be evaluated using a 0-10 Likert scale (0=no pain, 10= worst imaginable pain) about 1 hour post-operatively. Pain will be evaluated again by study personnel using the same scale on post-operative day #1, about 24 hours after initial block placement. If the patient is discharged home prior to the post-operative day #1 assessment, a phone interview will be performed 24 hours following the block to evaluate the post-operative day #1 scores and monitor for adverse events. Additional pain scores will be documented in the electronic medical record by nursing staff per protocol, and will be collected by study personnel.
During the intraoperative and post-operative period, the patient will continue to receive an appropriate multimodal analgesic regimen as necessary to adequately control the pain. No pain control method will be withheld from the patient as a result of participating in the study.
Patient satisfaction scores will also be used as a measure to evaluate quality of perioperative pain management. These scores will be assessed on post-operative day #1 on a scale of 1 to 5 (Poor=1, Fair=2, Good=3 Very good=4, Excellent=5).
During follow-up on post-operative day #1, the patients will also be asked for an estimate on duration and quality of sleep to help assess their general comfort level during their first post-operative night.
During the routine post-operative visit, an assessment of post-operative nausea and vomiting will be made by asking the patient directly. Chart review looking for post-operative antiemetic usage will also be evaluated to assess the presence of post-operative nausea and vomiting.
The decision as to whether or not to perform a serratus anterior plane block (SAPB) will be made independent from the introduction of the patient to the study. Therefore, the patient's choice to receive a SAPB will not be affected by the introduction of the study or their desire to participate in a clinical investigation. A multimodal intraoperative anesthetic technique will be employed for all patients, and post-operative pain control will be managed by the patient's primary surgical team.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post-operative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sub-serratus regional block
Arm Type
Experimental
Arm Description
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.
Arm Title
Supra-serratus regional block
Arm Type
Active Comparator
Arm Description
A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.35%
Other Intervention Name(s)
Ropivacaine
Intervention Description
The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Measures number of milligrams morphine equivalents each subject receives
Time Frame
24 hours post block
Secondary Outcome Measure Information:
Title
Maximum Post-operative Pain Score
Description
Measures the change in pain scores on a 0-10 Numeric Rating Scale where 0 is no pain and 10 is the maximum pain.
Time Frame
24 hours post block
Title
Patient Satisfaction Scale
Description
Pain satisfaction with regards to post-operative pain management within the first 24 hours post op on a 1-5 Likert scale of (1 poor, 2 fair, 3 good, 4 very good, 5 excellent).
Time Frame
24 hours post block
Title
Number of Participants With Nausea/Vomiting
Description
Measures the type and frequency of anti-emetics subjects receive
Time Frame
24 hours post block
Title
Length of Stay
Description
Measures total number of days subject is hospitalized, including day of surgery
Time Frame
10 Days
Title
Sleep Duration Night of Postoperative Day 0
Description
Measures the total duration of sleep in minutes that subjects report sleeping on the night after surgery between postoperative days 0 and 1
Time Frame
24 hours post block
Title
Block Performance Time
Description
Measures total time for block to take effect
Time Frame
Time from procedure needle insertion until needle removal, estimate less than 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Machi, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Centers
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34364099
Citation
Edwards JT, Langridge XT, Cheng GS, McBroom MM, Minhajuddin A, Machi AT. Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing mastectomy: A randomized prospective trial. J Clin Anesth. 2021 Dec;75:110470. doi: 10.1016/j.jclinane.2021.110470. Epub 2021 Aug 5.
Results Reference
derived
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Serratus Anterior Plane Block in Patients Undergoing Mastectomy
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