Pain, PostoperativePhase 3NCT03183596
Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery
A Phase 3 study testing Bupivacaine and Dexamethasone in people with Pain, Postoperative, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide analgesia for breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing reconstructive breast surgery
Who cannot join
- Patients with allergies to the local anesthetic
- Patients who do no consent to regional anesthesia
- Patients in which serratus block would be contraindicated
- Patients whose anatomy preclude placement of the block
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249
About this study
Official title: Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery (Randomized, Pilot Study)
The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide analgesia for breast surgery. However, to our knowledge, there are no large studies that truly delineate the optimal injection site for the Serratus Anterior Plane Block.
Read the detailed description
Analgesia for reconstructive breast surgery can be a challenging undertaking; these women have often been through painful mastectomy procedures coupled with the mental and physical discomfort of chemotherapy and its attendant side effects. Additionally, the surgery itself can provoke significant pain; often requiring extensive dissection of soft tissue and muscle to provide flap coverage as well the real discomfort of tissue expansion. The literature has described 2 possible injection sites for the Serratus Anterior Block, however, no study has defined optimal location based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine, Dexamethasone
- Keywords
- Deep Serratus Block, Reconstructive Breast Surgery, Superficial Serratus block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine, Sensorcaine
20-60cc of 0.25% Bupivacaine
DexamethasoneDrug
Also called Ozurdex, Decadron, DexPak, Maxidex, Baycadron
2-4mg of Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Deep Serratus Anterior Block | Active comparator | Patients in the "deep" Serratus Anterior Block (DSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone deposited deep to the serratus. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting. Receives: Drug: Bupivacaine; Drug: Dexamethasone |
| Superficial Serratus Anterior Block | Active comparator | Patients in the "superficial" Serratus Anterior Block (SSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting. Receives: Drug: Bupivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Pain Score
Collection of pain scores (VAS) until approximately 48 hours post-operatively
Measured: baseline to 48 hrs postoperatively
Secondary outcomes (3)
Average Opioid consumption
Average opioid consumption 48hrs postoperatively between study group and control
Measured: 48 hrs postoperatively
Length of Stay
Number of days in the hospital
Measured: baseline to 72 hrs post-operatively
PONV Medications
Mean time onset use of rescue PONV medications postoperatively
Measured: baseline to 48 hrs post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startDec 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Principal investigator determination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There has been no large, randomized study to define optimal location of injection based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Godlewski, University of Alabama at Birmingham
- Investigators
- Christopher Godlewski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183596
- Sponsor's protocol ID
- F000000000
- Status last verified
- May 2018
- First submitted
- 7 Jun 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Injection Site for Serratus Anterior Plane Block in Reconstructive Breast Surgery (Randomized, Pilot Study)
- ClinicalTrials.gov ID
- NCT03183596
- Acronym / sponsor ID
- F000000000
- Conditions
- Pain, Postoperative
- Keywords
- Deep Serratus Block, Reconstructive Breast Surgery, Superficial Serratus block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator determination
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The novel introduction of various chest wall blocks such as the Pecs I and II/modified Pecs blocks as well as the Serratus Anterior Plane Block have extended the application of perioperative regional anesthesia to provide analgesia for breast surgery. However, to our knowledge, there are no large studies that truly delineate the optimal injection site for the Serratus Anterior Plane Block.
Detailed description
Analgesia for reconstructive breast surgery can be a challenging undertaking; these women have often been through painful mastectomy procedures coupled with the mental and physical discomfort of chemotherapy and its attendant side effects. Additionally, the surgery itself can provoke significant pain; often requiring extensive dissection of soft tissue and muscle to provide flap coverage as well the real discomfort of tissue expansion. The literature has described 2 possible injection sites for the Serratus Anterior Block, however, no study has defined optimal location based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There has been no large, randomized study to define optimal location of injection based on analgesia and duration. Patients will be randomized to receive a "deep" Serratus Anterior Block (DSAB) where local anesthetic is deposited deep to the serratus or a "superficial" Serratus Anterior Block (SSAB) where the local anesthetic is placed between serratus and latissimus dorsi.
| Arm | Type | Receives |
|---|---|---|
| Deep Serratus Anterior Block | Active comparator | Drug: Bupivacaine, Drug: DexamethasonePatients in the "deep" Serratus Anterior Block (DSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone deposited deep to the serratus. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting. |
| Superficial Serratus Anterior Block | Active comparator | Drug: Bupivacaine, Drug: DexamethasonePatients in the "superficial" Serratus Anterior Block (SSAB) group will have 20-60cc of 0.25% bupivacaine and 2-4mg of dexamethasone placed between serratus and latissimus dorsi. The investigator will then evaluate the difference based on pain scores, opiate consumption, length of hospital stay, as well as nausea and vomiting. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing reconstructive breast surgery
Key exclusion criteria (4 listed)
- Patients with allergies to the local anesthetic
- Patients who do no consent to regional anesthesia
- Patients in which serratus block would be contraindicated
- Patients whose anatomy preclude placement of the block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: Marcaine, Sensorcaine20-60cc of 0.25% Bupivacaine | Drug | Deep Serratus Anterior Block, Superficial Serratus Anterior Block |
| DexamethasoneAlso: Ozurdex, Decadron, DexPak, Maxidex, Baycadron2-4mg of Dexamethasone | Drug | Deep Serratus Anterior Block, Superficial Serratus Anterior Block |
Primary outcome
Total Pain Score
Time frame: baseline to 48 hrs postoperatively
Collection of pain scores (VAS) until approximately 48 hours post-operatively
3 secondary outcomes
Average Opioid consumption
Time frame: 48 hrs postoperatively
Length of Stay
Time frame: baseline to 72 hrs post-operatively
PONV Medications
Time frame: baseline to 48 hrs post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Godlewski, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and Dexamethasone in people with Pain, Postoperative, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pain Score (time frame: baseline to 48 hrs postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.