Pectoral Block in Breast Reduction for Pain Control
ConditionMacromastia (Symptomatic)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCarilion Clinic
About this trial
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity.
The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing breast reduction surgery
Women older than age 18 and under age 75
Stable breast size for at least 1 year
Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs
Disqualifiers
History of chronic pain controlled with prescribed narcotics
English as non-primary language
No access to email or internet
Positive pre-surgery pregnancy test
Trial design
Design model
Parallel
Treatments tested in this trial
Pectoral II Nerve Block
Procedure/SurgeryThe Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve.
Post Operative Pain Relievers
DrugParticipants will receive the same postoperative instructions in both groups. Participants will be instructed to alternate acetaminophen and ibuprofen every 6 hours. Participants will also receive a paper prescription for a narcotic pain medication if pain is not adequately controlled by the over-the-counter products
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: PEC II block groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative pain control regimen
Participants are administered postoperative surveys on days 1, 3, and 7. These surveys assess type of analgesic medication usage and frequency. The primary purpose is to assess narcotic usage between the two groups to observe a reduction or elimination in narcotic usage in the control group
Time frame
From enrollment to completion of the study is approximately 3 weeks2
Postoperative PROMIS pain intensity survey
Participants are administered a postoperative survey on days 1, 3, and 7. This survey asks participants to rate their pain at its worst, the average intensity level, and the level of pain intensity while taking the survey. This is a numbered survey from 1-5 with 1=no pain, 2=mild, 3=moderate, 4=severe, and 5= very severe
Time frame
Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeksSponsors and contacts
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Source ClinicalTrials.gov