Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Nerve Block Clinical Trial

Official title:

The Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03143530
• Other study ID #: 160419
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: August 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia, Postoperative
• Mastectomy
• Nerve Block

Intervention

Procedure:
• Pectoralis 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).

Drug:
• Normal 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
• Ropivacaine 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery-27 score at baseline	Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline	Baseline
Primary	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	Post operative day 1
Primary	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	Post operative day 7
Primary	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	Post operative day 30
Primary	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	Post operative day 90
Secondary	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.	90 days
Secondary	Comparison of Numerical Rating Scale-11 (NRS-11) with movement	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.	90 days
Secondary	Duration of postoperative analgesia	Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively.	Up to 24 hours