At a glance
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A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Serratus Plane and Paravertebral Nerve Blocks
In Brief
A Phase 4 clinical trial evaluating Serratus Plane block (single injection) and Paravertebral block (single injection) for Breast Surgery. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
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.