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Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery

NCT04742309 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-06-26

Study results available
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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.

Conditions

  • Breast Surgery

Interventions

DRUG

Pecs-2 block (single injection)

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.

DRUG

Paravertebral block (single injection)

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.

Sponsors & Collaborators

Principal Investigators

  • Brian M Ilfeld, MD,MS · UCSD Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742309 on ClinicalTrials.gov