Clinical trial NCT03143530: Effect of Pectoralis Block on Analgesia After Simple Mastectomy
Official title: The Effect of Pectoralis Block on Analgesia After Simple Mastectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Mastectomy
Nerve Block
Analgesia, Postoperative
Keywords: Ropivacaine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2017-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery-27 score at baseline
timeFrame: Baseline
measure: Quality of Recovery-27 score at post operative day 1
timeFrame: Post operative day 1
measure: Quality of Recovery-27 scores at post operative day 7
timeFrame: Post operative day 7
measure: Quality of Recovery-27 scores at post operative day 30
timeFrame: Post operative day 30
measure: Quality of Recovery-27 scores at post operative day 90
timeFrame: Post operative day 90
Secondary outcomes:
measure: Comparison of Numerical Rating Scale-11 (NRS-11) at rest
timeFrame: 90 days
measure: Comparison of Numerical Rating Scale-11 (NRS-11) with movement
timeFrame: 90 days
measure: Duration of postoperative analgesia
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Uma Shastri, MD
role: PRINCIPAL_INVESTIGATOR
References: