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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Block | Procedure | Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid consumption | Duration of actual surgical procedure | |
| Post-operative opioid consumption | End of surgical procedure until 7 days after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Brull, MD FRCP | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33492696 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo Block | Procedure | Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line |
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| ropivacaine | Drug | Drug indicated for regional anesthesia |
|
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| epinephrine | Drug | Drug indicated to prolong the action of regional anesthesia |
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| sterile saline | Other | Neutral injection (no drug involved) |
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| Duration phase I and phase II recovery |
Duration of stay in PACU and in surgical day care |
| 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) | 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 | Completion of block to 3 months postoperatively |
| Satisfaction with analgesia | Scale of 0-10 (0=Not Satisfied, 10=Very Satisfied) | End of surgical procedure to 3 months postoperatively |
| Quality of recovery score (QoR) | Completion of questionnaire (QoR) done by patient. | Discharge from hospital until 24 hours post-op |
| Pain assessment | Persistent postsurgical pain | Assessment to be done again @ 6 weeks and 3 months postoperatively. Simple question requiring a yes or no response. |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |