Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies

NCT02822196 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HSC-MS-16-0467
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies. SPECIFIC AIMS Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.

Conditions

Breast Cancer; Mastectomy; Regional Anesthesia; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy of SPB block vs thoracic PVB

  Efficacy of SPB block vs thoracic PVB block as described by reduce post operative pain score and reduce requirement for Narcotics.

  6 months

Secondary Outcomes (4)

• Onset and duration of block

  6 months

• Post-operative rescue analgesia

  up to 24 hours

• Development of chronic incisional pain

  24 and 48 hours

• Pain related assessment scores as described in the Pain Detect Questionnaire

  6 months

Study Arms (2)

Serratus Anterior Muscle Plane Block

EXPERIMENTAL

The US probe will be placed in the mid-axillary line at the level of the 5th intercostal space. The latissimus dorsi, teres major and serratus muscles will be identified. Using in-plane approach, the block needle (22 G, 50 mm) will be inserted until the tip is visualized between the serratus anterior muscle and the intercostal muscles. As an extra reference point thoracodorsal artery will be used which aids in the identification of the plane superficial to the serratus muscle. After negative aspiration of blood, local anesthetic (20 ml of 0.25 % bupivacaine) will be injected and visualized in real-time.

Drug: Bupivacaine

Thoracic Paravertebral Block

ACTIVE COMPARATOR

The spinous processes of T1- T5 will be identified and at parasagittal plan at 2.5 cm, skin wheel will be raised using 1% lidocaine. A 20-gauge, bevel needle will be advanced until the transverse process is located. The depth from skin to transverse process will be marked/identified by needle marking. The needle will be withdrawn 1-2 cm and angled down.The needle will be re-advanced 1cm past the initial marking. After negative aspiration, 4-5 ml of 0.25% bupivacaine will be slowly injected. The same procedure will be repeated at each level from T2 to T6 ensuring total dose of bupivacaine does not exceed the maximum dose recommended.

Drug: Lidocaine; Drug: Bupivacaine

Interventions

Lidocaine DRUG

Local Anesthesia using 1% Lidocaine

Also known as: 1% Lidocaine

Thoracic Paravertebral Block

Bupivacaine DRUG

Local Anesthesia using 0.25% Bupivacaine

Also known as: 0.25% Bupivacaine

Serratus Anterior Muscle Plane Block; Thoracic Paravertebral Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Simple or radical unilateral mastectomy with or without axillary lymph node dissection.
• American Society of Anesthesia (ASA) I, II and III

You may not qualify if:

• Morbid obesity (body mass index \> 40 kg/m2);
• Renal insufficiency (creatinine \> 2.0 mg/DL),
• Current chronic analgesic therapy (daily use \> 4 weeks),
• History of opioid dependence, pregnancy.
• Allergy to local anesthetic
• Rash/infection at the area of injection
• Coagulation disorder
• Patients on anticoagulation

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Memorial Hermann Hospital: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sara Guzman-Reyes, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 4, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)