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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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).
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
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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Quality of Recovery-27 score at baseline
Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline
Time frame: Baseline
Quality of Recovery-27 score at 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
Time frame: Post operative day 1
Quality of Recovery-27 scores at 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
Time frame: Post operative day 7
Quality of Recovery-27 scores at 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
Time frame: Post operative day 30
Quality of Recovery-27 scores at 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
Time frame: Post operative day 90
Comparison of Numerical Rating Scale-11 (NRS-11) at rest
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.
Time frame: 90 days
Comparison of Numerical Rating Scale-11 (NRS-11) with movement
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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.
Time frame: 90 days
Duration of postoperative analgesia
Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.
Time frame: Up to 24 hours