Phase 4
N=119
Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery
Breast Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04742309 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Recovery Room Numeric Rating Scale Pain Scores — 3.3; 1.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pecs-2 block (single injection) (Drug); Paravertebral block (single injection) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Room Numeric Rating Scale Pain Scores |
3.3; 1.3 | — |
| PRIMARY Cumulative Operating and Recovery Room Opioid Consumption |
18; 10 | — |
| SECONDARY Nausea and Vomiting |
0.1; 0.1 | — |
| SECONDARY Time of First Opioid Use |
— | — |
| SECONDARY Time of Block Resolution |
— | — |
| SECONDARY Opioid (Oxycodone) Consumption |
5; 5 | — |
| SECONDARY Worst Pain Measured Using the Numeric Rating Scale Pain Score |
5; 3 | — |
| SECONDARY Lowest Pain Measured Using the Numeric Rating Scale Pain Score |
3; 0 | — |
| SECONDARY Average Pain Measured Using the Numeric Rating Scale Pain Score |
3; 1.8 | — |
| SECONDARY Current Pain Measured Using the Numeric Rating Scale Pain Score |
2; 1 | — |
| SECONDARY Awakenings Due to Pain |
0.2; 0.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2).
- Renal insufficiency ( abnormal preoperative creatinine or eGFR)
- 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.
- Inability to communicate with the investigators or hospital staff.
- Pregnancy
- Planned regional analgesic with perineural catheter placement
- Incarceration
- Known allergy to amide local anesthetics.
Data sourced from ClinicalTrials.gov (NCT04742309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.