Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption

Brief Summary
Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting
Brief Title
Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption
Detailed Description
Breast surgery is among the most common procedures performed at ambulatory surgery centers. Whether for cosmetic or cancer indications, mastectomy and reduction mammoplasty are being performed under general anesthesia with standard multimodal pharmacologic analgesia. Regional anesthetic techniques have become increasingly prevalent in the management of postoperative analgesia. In oncologic surgery, regional anesthetic techniques have demonstrated a lower incidence of recurrence or metastasis of breast cancer compared to opioid analgesia. The breast has complex innervation, receiving innervation from C5-T7, thus posing a challenge to the regional anesthesiologist.

Current regional techniques for breast and other thoracic surgeries, such as open heart surgery, include the PEC I, PEC II, serratus anterior block as well as the paravertebral block. Of these options, the paravertebral block is heralded as the gold standard for multimodal analgesia in breast surgery. Unfortunately, the paravertebral block carries with it the risk of pneumothorax due to its proximity to the pleura. This risk is also increased when an inexperienced provider is performing the block, which is common on an academic institution. As a result, the PEC I, PEC II and serratus anterior blocks have gained traction, is that they carry less risk of adverse events. One drawback of the PEC blocks and serratus anterior block is that they may not achieve adequate anterior spread and complete coverage of the surgical field, making them less effective at providing adequate post-operative analgesia. Due to these drawbacks, the erector spinae plane block (ESPB) has begun to gain traction as the regional technique of choice for breast surgery. The ESPB is a myofascial block alternative to the paravertebral block. \[1\] It is performed by injecting local anesthetic in the plane between the erector spinae muscle and the spinal transverse process. The ESPB is thought to be safer than the paravertebral block because the transverse process acts as a barrier to the pleura. It has been postulated that local anesthetic spread reaches the paravertebral space and in fact, cadaveric studies have shown dye spreading to involve the ventral and dorsal rami of spinal nerves. It is because of this mechanism of action that this block has been call the "paravertebral by proxy." The spread of the local anesthetic is volume-dependent, and has been seen to anesthetize between 3-8 vertebral levels when using local anesthetic volumes of 15-20mL. The ESPB has been used successfully for analgesia in open-heart surgery as well as in chronic thoracic neuropathy secondary to herpetic neuralgia. Proponents of the erector spinae block prefer it to the paravertebral block for its ease to perform and seemingly safer profile.

The investigators seek to explore the proposed benefits of the erector spinae plane block in our patients undergoing bilateral breast reduction mammoplasty. Reducing overall opioid use and enhancing recovery after surgery are areas of great importance in the ambulatory, outpatient setting. The investigators hope to show the positive impact of ESPB on both of important perioperative factors.
Completion Date
Completion Date Type
Actual
Conditions
Anesthesia
Block
Eligibility Criteria
Inclusion Criteria:

* Patients undergoing reduction mammoplasty
* Age \>18 years
* ASA class I-III

Exclusion Criteria:

* Patient refusal
* Renal insufficiency (defined as CKD stage 3 or greater)
* Infection at the skin at the site of needle puncture
* Known allergies to any study drugs
* Coagulopathy
* Severe asthmatics
* BMI \>40
* ASA 4 and 5
* Pre-existing pain disorder
* Regular consumption of chronic pain medication
* Failed block
* Diagnosis of OSA
Inclusion Criteria
Inclusion Criteria:

* Patients undergoing reduction mammoplasty
* Age \>18 years
* ASA class I-III

Gender
All
Gender Based
false
Keywords
erector spinae plane block
multimodal anesthesia
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT03954249
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10183
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Prospective Controlled Study Evaluating the Effectiveness of Bilateral Erector Spinae Plane Blocks in Addition to Standard Multimodal Analgesia at Reducing Opioid Consumption in Patients Undergoing Elective Mammoplasty in an Ambulatory Surgical Center
Primary Outcomes
Outcome Description
The cumulative dose of oral morphine equivalence used in the 24 hours post surgery in morphine equivalents.
Outcome Measure
Use of narcotics in first 24 hours
Outcome Time Frame
24 hours
Secondary Outcomes
Outcome Description
The occurrence of nausea and vomiting a subject encounters until they discharge from hospital.
Outcome Time Frame
Up to 1 day after surgery
Outcome Measure
Postoperative nausea and vomiting
Outcome Description
The amount of hours a subject stays in post anesthesia care unit (PACU).The time from arrival to PACU until discharge from PACU will be taken.
Outcome Time Frame
Up to 5 Hours in PACU
Outcome Measure
Length of stay in PACU
Outcome Description
Assessment of pain at different time points after surgery with an 11 point Numerical Rating Score(NRS) where 0 means no pain and 10 means worst imaginable pain.
Outcome Time Frame
Up to 5 Hours in PACU
Outcome Measure
Assessment of postoperative pain
Outcome Description
Assessment of patient satisfaction via a seven-point Likert scale, where 1 means extremely unsatisfied and 7 means extremely satisfied
Outcome Time Frame
Up to 1 day after surgery
Outcome Measure
Patient Satisfaction
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elilary Montilla Medrano
Investigator Email
emontill@montefiore.org
Investigator Phone