Effect of Pectoralis Block on Analgesia After Simple Mastectomy

Vanderbilt University Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Mastectomy; Nerve Block; Analgesia, Postoperative

Treatments: Drug: Ropivacaine Injection; Procedure: Pectoralis block; Drug: Normal saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03143530

160419

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Pectoralis Block with Ropivacaine

Active Comparator group

Description:

General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg)

Treatment:

Drug: Ropivacaine Injection

Procedure: Pectoralis block

Pectoralis Block with normal saline

Placebo Comparator group

Description:

General anesthesia + Pectoralis block with 30ml of normal saline injection

Treatment:

Drug: Normal saline injection

Procedure: Pectoralis block