Serratus Plane Versus Paravertebral Nerve Blocks for Breast Surgery

NCT03860974 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Serratus vs PVB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. Recently an alternative block has been reported: the serratus plane block.2 The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin as there are fewer anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB, therefore leakage of cerebrospinal fluid or injury to the spinal cord are less likely with the serratus compared to the PVB.3 There are, therefore, multiple theoretical reasons to prefer the serratus over the PVB. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB.4 The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm clinical trial.

Conditions

Breast Surgery

Keywords

regional anesthesia; paravertebral; erector spinae; nerve block

Outcome Measures

Primary Outcomes (2)

• Mean/Median Numeric Rating Scale Pain Score Within the Recovery Room

  Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes. The primary outcome measure will be the mean or median (depending on whether data is normally or not normally distributed) of all reported NRS within the recovery room following surgery and prior to recovery room discharge.

  Within the recovery room, averaging approximately 2 hours

• Mean/Median Opioid Consumption Within the Recovery Room

  Opioid consumption as measured in milligram morphine equivalents. The primary outcome measure will be the mean or median (depending on whether data is normally or not normally distributed) of the cumulative opioid consumption within the recovery room following surgery and prior to recovery room discharge.

  Within the recovery room following surgery and prior to recovery room discharge

Secondary Outcomes (15)

• Number of Participants Requiring an Anti-emetic Within the Recovery Room

  Within the recovery room, averaging approximately 2 hours

• Opioid Consumption After Recovery Room Discharge

  Between the recovery room discharge to the postoperative day 1 data collection phone call

• WORST Pain Measured Using the Numeric Rating Scale Pain Score

  Between the recovery room discharge to the postoperative day 1 data collection phone call

• Lowest Pain Measured Using the Numeric Rating Scale Pain Score

  between the recovery room discharge to the postoperative day 1 data collection phone call

• Average Pain Measured Using the Numeric Rating Scale Pain Score

  between the recovery room discharge to the postoperative day 1 data collection phone call

Study Arms (2)

Serratus Plane (single injection)

EXPERIMENTAL

A single injection serratus plane block will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL for unilateral surgery; 16 mL on each side for bilateral surgery)

Drug: Serratus Plane block (single injection)

Paravertebral (single injection)

ACTIVE COMPARATOR

Single injection paravertebral blocks will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL for unilateral surgery; 16 mL each side for bilateral surgery)

Drug: Paravertebral block (single injection)

Interventions

Serratus Plane block (single injection) DRUG

A single-injection serratus plane block will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL of local anesthetic for unilateral surgery; 16 mL of local anesthetic each side for bilateral surgery).

Serratus Plane (single injection)

Paravertebral block (single injection) DRUG

Single injection paravertebral blocks will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL for unilateral surgery; 16 mL each side for bilateral surgery). For paravertebral blocks without axillary involvement, this will be at the T3 and T5 levels. For paravertebral blocks with axillary involvement, this will be at the T2 and T4 levels. For unilateral PVBs, 10 mL of local anesthetic will be injected per level. For bilateral paravertebral blocks, 8 mL of local anesthetic will be injected per level.

Paravertebral (single injection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated
• analgesic plan includes a single-injection peripheral nerve block(s)
• age 18 years or older

You may not qualify if:

• morbid obesity as defined by a body mass index \> 40 (BMI=weight in kg / \[height in meters\]2)
• renal insufficiency (preoperative creatinine \> 1.5 mg/dL)
• chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• history of opioid abuse
• any comorbidity which results in moderate or severe functional limitation inability to communicate with the investigators or hospital staff
• pregnancy
• planned regional analgesic with perineural catheter placement
• incarceration

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University California San Diego

San Diego, California, 92103, United States

Location

Related Publications (1)

• Gabriel RA, Swisher MW, Sztain JF, Curran BP, Said ET, Abramson WB, Khatibi B, Alexander BS, Finneran JJ, Wallace AM, Armani A, Blair S, Dobke M, Suliman A, Reid C, Donohue MC, Ilfeld BM. Serratus anterior plane versus paravertebral nerve blocks for postoperative analgesia after non-mastectomy breast surgery: a randomized controlled non-inferiority trial. Reg Anesth Pain Med. 2021 Sep;46(9):773-778. doi: 10.1136/rapm-2021-102785. Epub 2021 Jun 22.

  PMID: 34158376 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

\*\* Regarding the time from nerve block placement until block resolution, this outcome was erroneously left off of the case report forms, so we did not collect the data for this outcome measure.

Results Point of Contact

• Title: Brian Ilfeld
• Organization: University of California, San Diego

bilfeld@health.ucsd.edu

8582493660

Study Officials

• Brian M Ilfeld, MD, MS

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: May 9, 2019
• Primary Completion: February 12, 2021
• Study Completion: February 13, 2021
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)