Serratus Anterior Plane Block in Patients Undergoing Mastectomy

NCT03154658 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU 122016-011
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

Conditions

Pain, Post-operative

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Measures number of milligrams morphine equivalents each subject receives

  24 hours post block

Secondary Outcomes (6)

• Maximum Post-operative Pain Score

  24 hours post block

• Patient Satisfaction Scale

  24 hours post block

• Number of Participants With Nausea/Vomiting

  24 hours post block

• Length of Stay

  10 Days

• Sleep Duration Night of Postoperative Day 0

  24 hours post block

Study Arms (2)

Sub-serratus regional block

EXPERIMENTAL

A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.

Drug: Ropivacaine 0.35%

Supra-serratus regional block

ACTIVE COMPARATOR

A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.

Drug: Ropivacaine 0.35%

Interventions

Ropivacaine 0.35% DRUG

The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.

Also known as: Ropivacaine

Sub-serratus regional block; Supra-serratus regional block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18 years or older
• Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

You may not qualify if:

• Any known sensory deficit of the anterolateral chest wall.
• Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
• Pregnancy
• American Society of Anesthesiology classification greater than 3
• Allergy to amide local anesthetic medications
• Chronic pain conditions
• Preoperative opioid use greater than 20 oral morphine equivalents per day
• Any coagulation abnormality which would be a contraindication for block placement
• Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
• Body mass index \>50
• Incarceration
• Inability to understand study procedures including inability to understand the English language
• Inability to provide adequate informed consent
• Refusal to participate in the study

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Centers

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Edwards JT, Langridge XT, Cheng GS, McBroom MM, Minhajuddin A, Machi AT. Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing mastectomy: A randomized prospective trial. J Clin Anesth. 2021 Dec;75:110470. doi: 10.1016/j.jclinane.2021.110470. Epub 2021 Aug 5.

  PMID: 34364099 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Anthony Machi M.D.
• Organization: University of Texas Southwestern

anthony.machi@utsouthwestern.edu

2146486400

Study Officials

• Anthony Machi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized interventional prospective model to investigate effect of block placement in two treatment arms. Opioid consumption in the first 24 hours after the operation will be main outcome variable.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 16, 2017
• Study Start: April 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 16, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)