At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Pecs-2 and Paravertebral Nerve Blocks
In Brief
A Phase 4 clinical trial evaluating Pecs-2 block (single injection) and Paravertebral block (single injection) for Breast Surgery. Completed, enrolled 119 participants across 1 site.
Detailed Summary
Following painful surgical procedures of the breast, postoperative analgesia is often provided with a nerve block called a "paravertebral" block. For intense, but shorter-duration acute pain, a single-injection of numbing medicine is used which lasts about 12 hours. Recently, a new type of block has been reported: the "Pecs-2" block. The theoretical benefits include ease of administration since it is closer to the skin (less deep) compared with the paravertebral block and therefore easier to identify and target with ultrasound (therefore increasing success rate); and, a lower risk of complications. Lastly, it might be easier to insert a tiny tube which would allow additional numbing medicine to be injected. There are, therefore, multiple theoretical reasons to prefer the Pecs-2 over the paravertebral nerve block. Unfortunately, it remains unknown if the pain control provided by this new type of block is comparable to that provided with the older block. The investigators therefore propose to compare these two blocks with a clinical study.
Study Details
Timeline
Interventions
For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.
For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.