Analgesia, Postoperative, Mastectomy, Nerve Block
Conditions
Keywords
Ropivacaine
Brief summary
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
Detailed description
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
Interventions
PROCEDUREPectoralis block
Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).
DRUGNormal saline injection
Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
DRUGRopivacaine Injection
Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
Sponsors
Duke University
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.
Intervention model description
Participants will be assigned to one of two of the following groups for the duration of the study. 1. General anesthesia + pectoralis block with Ropivacaine 30ml of 0.25% (75mg) 2. General anesthesia + sham block with 30ml of normal saline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health) * Patients undergoing simple mastectomy
Exclusion criteria
* -Patient Refusal * Allergy to local anesthetics * Inability to communicate in English * Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery * Existing nerve injuries or sensory deficits * Conversion to anesthesia via an endotracheal tube
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-27 scores at post operative day 90 | Post operative day 90 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90 |
| Quality of Recovery-27 score at post operative day 1 | Post operative day 1 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1 |
| Quality of Recovery-27 scores at post operative day 7 | Post operative day 7 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7 |
| Quality of Recovery-27 scores at post operative day 30 | Post operative day 30 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30 |
| Quality of Recovery-27 score at baseline | Baseline | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Numerical Rating Scale-11 (NRS-11) with movement | 90 days | Comparison of patient reported pain assessment while with movement using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. |
| Duration of postoperative analgesia | Up to 24 hours | Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively. |
| Comparison of Numerical Rating Scale-11 (NRS-11) at rest | 90 days | Comparison of patient reported pain assessment while at rest using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. |
Countries
United States
Outcome results
None listed