Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

Not Applicable

Completed

• Conditions: Breast Neoplasms; Anesthesia
• Interventions: Procedure: Multiple injection paravertebral blocks; Procedure: Single injection paravertebral block

• Registration Number: NCT02852421
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of recovery, reduced chronic pain and possibly reduced metastasis with breast cancer. Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With multiple injections, the risk is increased for a pleural, an intraneural, and/or an intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use of ultrasound imaging enables real-time needle visualization during the procedure. This may improve efficacy and reduce the chances of complication like pneumothorax. Currently, there are no data comparing ultrasound-guided single injection technique with multiple injections technique with regards to extent of spread for PVB. Our objective is to investigate the extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one versus five paravertebral sites for patients undergoing major breast surgery. In addition, the investigators wish to compare the performance time and duration of analgesia.

Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or without axillary node dissection will be randomized to receive either single or multiple injections PVB. The PVB will be performed in prone position under real-time ultrasound guidance using a para-sagittal approach.The patients in single injection group will receive single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections. Patients in the multiple injection group will receive five injections of PVB from T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick method will be used to assess the extent of dermatomal blockade, 20 minutes following the completion of procedure. All patients will receive a standardized general anesthesia for the surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure, total spinal, will be recorded.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-07-15
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Females, age 18 to 80 years, scheduled to receive unilateral mastectomy surgery, with or without axillary node dissection
• Able to give informed consent
• Able to cooperate with study process
• Availability of home telephone.

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Exclusion Criteria

• Patient refusal or lack of informed consent
• allergy to local anesthetic and other medications used in the study
• Bilateral mastectomies
• Coexisting hematological disorder or with deranged coagulation parameters
• Pre-existing major organ dysfunction such as hepatic and renal failure
• Significant thoracic kyphoscoliosis
• History of previous thoracic surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple injection paravertebral blocks	Multiple injection paravertebral blocks	Patients in this group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% "ropivacaine" was injected at each level.
Single injection paravertebral block	Single injection paravertebral block	Patients in single injection group will receive single injection paravertebral blocks at T3-T4 level with 25 ml of 0.5% "ropivacaine" and four subcutaneous sham injections.

Primary Outcome Measures

Name	Time	Method
Sensory dermatomal spread	20 minutes	20 minutes after block performance

Secondary Outcome Measures

Name	Time	Method
Time to performance of procedure	Duration of procedure
Cephalic and caudal dermatomal spread	20 minutes after block performance
Incidence of complication	24 hours	Follow-up phone call
VAS pain scores in PACU	6 hours	During PACU stay
Duration of self-reported numbness at the surgical site	24 hours	At follow-up phone call

Trial Locations

Locations (2)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre University Hospital; 🇨🇦 London, Ontario, Canada