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Clinical trial

A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Pecs-2 and Paravertebral Nerve Blocks

ID
Name
Pecs vs PVB
Description
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.
Trial arms
Trial start
2021-02-25
Estimated PCD
2023-08-31
Trial end
2023-08-31
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Pecs-2
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.
Arms:
Paravertebral
Size
138
Primary endpoint
Recovery Room Numeric Rating Scale Pain Scores
From arrival in the recovery room until recovery room discharge, assessed up to 12 hours total
Cumulative Operating and Recovery Room Opioid Consumption
From entering the operating room until recovery room discharge, assessed up to 24 hours
Eligibility criteria
Inclusion Criteria: 1. Undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated. 2. Analgesic plan includes a single-injection peripheral nerve block(s). 3. Age 18 years or older. Exclusion Criteria: 1. Morbid obesity as defined by a body mass index \> 40 (BMI=weight in kg / \[height in meters\]2). 2. Renal insufficiency ( abnormal preoperative creatinine or eGFR) 3. Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks). 4. History of opioid abuse. 5. Any comorbidity which results in moderate or severe functional limitation inability to communicate with the investigators or hospital staff. 6. Inability to communicate with the investigators or hospital staff. 7. Pregnancy 8. Planned regional analgesic with perineural catheter placement 9. Incarceration 10. Known allergy to amide local anesthetics.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Anesthesia teams in the operating rooms and recovery room nurses will be masked to treatment group assignment (therefore, the primary outcome measure collection). Outcomes assessor for the questionnaire involving secondary outcomes on the day following surgery will not be masked to treatment group, although subjects will remain masked.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 138, 'type': 'ACTUAL'}}
Updated at
2023-09-06

1 organization

2 products

1 indication

Organization
University of California, San Diego
Product
Pecs-2
Indication
Breast Surgery
Product
Paravertebral block