AnesthesiaNCT03954249
Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption
A study testing Erecto Spinae nerve block and Multimodal Analgesia in people with Anesthesia and Block, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Block
- What is being tested?
- Erecto Spinae nerve block and Multimodal Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 30 Dec 2021
- Phase
- Interventional
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing reduction mammoplasty
- Age >18 years
- ASA class I-III
Who cannot join
- 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
Show all 12Show fewer
- BMI >40
- ASA 4 and 5
- Pre-existing pain disorder
- Regular consumption of chronic pain medication
- Failed block
- Diagnosis of OSA
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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
Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting
Read the 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.
UPDATE (1/27/2026): The 'actual' Enrollment total has been updated from 76 to 78 on account of an error identified from the time the record was completed in May 2022.
- Conditions
- Anesthesia, Block
- Being tested
- Erecto Spinae nerve block, Multimodal Analgesia
- Keywords
- erector spinae plane block, multimodal anesthesia
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erecto Spinae nerve blockProcedure or surgery
The ESPB is a myofascial block alternative to the paravertebral block. 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.
Multimodal AnalgesiaProcedure or surgery
Patients in the control group will receive standard 100mg pregabalin PO, midazolam 2mg IV, fentanyl 100mcg IV.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae nerve block group | Experimental | Receive multimodal analgesia and in addition erector spinae plane block Receives: Procedure: Erecto Spinae nerve block |
| Multimodal Analgesia group | Active comparator | Receive standard multimodal analgesia Receives: Procedure: Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of narcotics in first 24 hours
The cumulative dose of oral morphine equivalence used in the 24 hours post surgery in morphine equivalents.
Measured: 24 hours
Secondary outcomes (4)
Postoperative nausea and vomiting
The occurrence of nausea and vomiting a subject encounters until they discharge from hospital.
Measured: Up to 1 day after surgery
Length of stay in PACU
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.
Measured: Up to 5 Hours in PACU
Assessment of postoperative pain
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.
Measured: Up to 5 Hours in PACU
Patient Satisfaction
Assessment of patient satisfaction via a seven-point Likert scale, where 1 means extremely unsatisfied and 7 means extremely satisfied
Measured: Up to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start7 Nov 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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.
- More trials run by Montefiore Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elilary Montilla Medrano, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954249
- Sponsor's protocol ID
- 2019-10183
- Other IDs
- 2019
- Status last verified
- Jan 2026
- First submitted
- 15 May 2019
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khandaker R, Razzaki T, Aquino M, Bui B, Labins J, Randolph R, Rosenberg J, Choice C, Steinberg S, Montilla Medrano E. 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: a randomized clinical trial. Reg Anesth Pain Med. 2026 Jul 9:rapm-2026-107819. doi: 10.1136/rapm-2026-107819. Online ahead of print.
PubMed 42425699
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03954249
- Acronym / sponsor ID
- 2019-10183
- Conditions
- Anesthesia, Block
- Keywords
- erector spinae plane block, multimodal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 May 2019 (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.
Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting
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.
UPDATE (1/27/2026): The 'actual' Enrollment total has been updated from 76 to 78 on account of an error identified from the time the record was completed in May 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae nerve block group | Experimental | Procedure: Erecto Spinae nerve blockReceive multimodal analgesia and in addition erector spinae plane block |
| Multimodal Analgesia group | Active comparator | Procedure: Multimodal AnalgesiaReceive standard multimodal analgesia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing reduction mammoplasty
- Age >18 years
- ASA class I-III
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Erecto Spinae nerve blockThe ESPB is a myofascial block alternative to the paravertebral block. 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. | Procedure or surgery | Erector Spinae nerve block group |
| Multimodal AnalgesiaPatients in the control group will receive standard 100mg pregabalin PO, midazolam 2mg IV, fentanyl 100mcg IV. | Procedure or surgery | Multimodal Analgesia group |
Primary outcome
Use of narcotics in first 24 hours
Time frame: 24 hours
The cumulative dose of oral morphine equivalence used in the 24 hours post surgery in morphine equivalents.
4 secondary outcomes
Postoperative nausea and vomiting
Time frame: Up to 1 day after surgery
Length of stay in PACU
Time frame: Up to 5 Hours in PACU
Assessment of postoperative pain
Time frame: Up to 5 Hours in PACU
Patient Satisfaction
Time frame: Up to 1 day after surgery
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 29 Jan 2026.
- Derived from this study: PubMed 42425699Khandaker R, Razzaki T, Aquino M, Bui B, Labins J, Randolph R, Rosenberg J, Choice C, Steinberg S, Montilla Medrano E. 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: a randomized clinical trial. Reg Anesth Pain Med. 2026 Jul 9:rapm-2026-107819. doi: 10.1136/rapm-2026-107819. Online ahead of print.
- 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.
Elilary Montilla Medrano, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erecto Spinae nerve block and Multimodal Analgesia in people with Anesthesia and Block, run by Montefiore Medical Center 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 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 29 Jan 2026. 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.
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?
Use of narcotics in first 24 hours (time frame: 24 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 NCT03954249, 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 29 Jan 2026.