AnesthesiaPhase 2/3NCT02453516
The Effect of the Serratus Block on Pain Control After Breast Surgery
A Phase 2/3 study testing Serratus Block, ropivacaine and epinephrine in people with Anesthesia, run by Women's College Hospital at 1 site in Canada.
Trial summary
Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Serratus Block, ropivacaine and epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 Oct 2014to 11 Dec 2019
- Phase
- Phase 2/3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
- undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
- day surgery procedures
Who cannot join
- inability to understand or to provide consent
- inability or unwillingness to comply with required follow-up assessments
- psychiatric disorder affecting patient assessment
- contraindication to regional anesthesia, e.g., coagulopathy
- allergy to local anesthestic
- chronic pain and/or chronic use of opioids with a daily use of over 30mg oxycodone or equivalent per day
Show all 12Show fewer
- contraindication to a component of multimodal analgesia
- preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
- infection near the injection site
- pregnancy
- BMI >35
- complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.
Read the detailed description
The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.
- Conditions
- Anesthesia
- Being tested
- Serratus Block, Placebo Block, ropivacaine, epinephrine, sterile saline
- Keywords
- Serratus Block, Breast Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus BlockProcedure or surgery
Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
Placebo BlockProcedure or surgery
Also called Control Group - Placebo Comparator
Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line
ropivacaineDrug
Also called Naropin HCL
Drug indicated for regional anesthesia
epinephrineDrug
Also called Adrenaline Chloride
Drug indicated to prolong the action of regional anesthesia
sterile salineOther
Also called Sodium Chloride
Neutral injection (no drug involved)
| Study group | Role | What they receive |
|---|---|---|
| Serratus Block Group | Experimental | Patients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia Receives: Procedure: Serratus Block; Drug: ropivacaine; Drug: epinephrine |
| Placebo Block - Control Group | Placebo comparator | Patients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia. Receives: Procedure: Placebo Block; Other: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain scores
The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS). The mean of these scores at the 3 different time points will be calculated.
Measured: Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..
Secondary outcomes (8)
Intraoperative opioid consumption
Measured: Duration of actual surgical procedure
Post-operative opioid consumption
Measured: End of surgical procedure until 7 days after surgery
Duration phase I and phase II recovery
Duration of stay in PACU and in surgical day care
Measured: Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,
Opioid side-effects
Opioid-related side effects (nausea, vomiting, pruritis)
Measured: End of surgical procedure to 7 days following surgery
Block-related side-effects
Presence/absence of block-related side effects such as bruising, infection, systemic toxicity, persistent numbness or shoulder weakness
Measured: Completion of block to 3 months postoperatively
Satisfaction with analgesia
Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied)
Measured: End of surgical procedure to 3 months postoperatively
Quality of recovery score (QoR)
Completion of questionnaire (QoR) done by patient.
Measured: Discharge from hospital until 24 hours post-op
Pain assessment
Persistent postsurgical pain
Measured: Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start29 Oct 2014
- Primary completion11 Sep 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD FRCP, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453516
- Sponsor's protocol ID
- 2014-0051-E
- Status last verified
- Jan 2020
- First submitted
- 13 May 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.
PubMed 33492696
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Serratus Block on Analgesia After Breast Surgery A Randomized Controlled Double-Blinded Study
- ClinicalTrials.gov ID
- NCT02453516
- Acronym / sponsor ID
- 2014-0051-E
- Conditions
- Anesthesia
- Keywords
- Serratus Block, Breast Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- 29 Oct 2014 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 25 May 2015 (estimated)
- 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.
Surgery for breast cancer is associated with significant pain. The serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.
Detailed description
The prevalence of severe acute postoperative pain after breast surgery is high. Regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. The search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. The serratus block is a promising technique that may combine these advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Block Group | Experimental | Procedure: Serratus Block, Drug: ropivacaine, Drug: epinephrinePatients will receive a preoperative ultrasound-guided serratus block with 0.4ml/kg (max.30ml) of ropivacaine 0.5% with 1:4000,000 epinephrine injected between the serratus anterior (superficial) and external intercostal (deep) muscles followed by subsequent general anesthesia |
| Placebo Block - Control Group | Placebo comparator | Procedure: Placebo Block, Other: sterile salinePatients will receive a preoperative placebo injection with a subcutaneous injection of 1ml normal sterile saline solution in the midaxillary line and the ultrasound probe will be used to simulate the pressure and block duration associated with the serratus block. These patients will then receive general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
- undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy
- day surgery procedures
Key exclusion criteria (12 listed)
- inability to understand or to provide consent
- inability or unwillingness to comply with required follow-up assessments
- psychiatric disorder affecting patient assessment
- contraindication to regional anesthesia, e.g., coagulopathy
- allergy to local anesthestic
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 |
|---|---|---|
| Serratus BlockUltrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles | Procedure or surgery | Serratus Block Group |
| Placebo BlockAlso: Control Group - Placebo ComparatorSubcutaneous injection of 1ml sterile normal saline solution in the midaxillary line | Procedure or surgery | Placebo Block - Control Group |
| ropivacaineAlso: Naropin HCLDrug indicated for regional anesthesia | Drug | Serratus Block Group |
| epinephrineAlso: Adrenaline ChlorideDrug indicated to prolong the action of regional anesthesia | Drug | Serratus Block Group |
| sterile salineAlso: Sodium ChlorideNeutral injection (no drug involved) | Other | Placebo Block - Control Group |
Primary outcome
Post-operative pain scores
Time frame: Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..
The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS). The mean of these scores at the 3 different time points will be calculated.
8 secondary outcomes
Intraoperative opioid consumption
Time frame: Duration of actual surgical procedure
Post-operative opioid consumption
Time frame: End of surgical procedure until 7 days after surgery
Duration phase I and phase II recovery
Time frame: Admission to phase I recovery (PACU) until discharge from phase II recovery, total time is estimated up to 6 hours,
Opioid side-effects
Time frame: End of surgical procedure to 7 days following surgery
Block-related side-effects
Time frame: Completion of block to 3 months postoperatively
Satisfaction with analgesia
Time frame: End of surgical procedure to 3 months postoperatively
Quality of recovery score (QoR)
Time frame: Discharge from hospital until 24 hours post-op
Pain assessment
Time frame: Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 33492696Abdallah FW, Patel V, Madjdpour C, Cil T, Brull R. Quality of recovery scores in deep serratus anterior plane block vs. sham block in ambulatory breast cancer surgery: a randomised controlled trial. Anaesthesia. 2021 Sep;76(9):1190-1197. doi: 10.1111/anae.15373. Epub 2021 Jan 25.
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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.
Richard Brull, MD FRCP principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Serratus Block, ropivacaine and epinephrine in people with Anesthesia, run by Women's College Hospital at 1 site in Canada.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jan 2020. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative pain scores (time frame: Scores collected @ 3 different time points: admission to phase I recovery (PACU), admission to phase II recovery (day surgery unit), and discharge from day surgery unit The total time time is estimated to be up to 6 hours..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453516, which also lists 1 linked publication.
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 13 Jan 2020.