Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery
Completed · Phase 4
Conditions studied: Breast Surgery
In brief
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. The PVB has several limitations: it can decrease blood pressure, and very rare-but serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. 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: there are few 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. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB. There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.
Key facts
- Study ID
- NCT03549234
- Run by
- University of California, San Diego
- People needed
- 100
- Starts
- 2018-07-12
- Expected to finish
- 2019-05-08
- Last updated by the study team
- 2020-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UCSD Medical Center (Hillcrest and Thornton) — San Diego, California, United States
Full record on ClinicalTrials.gov
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