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Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

Randomized Prospective Study to Evaluate Efficacy and Safety of Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks for Breast Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02852421
Enrollment
70
Registered
2016-08-02
Start date
2013-08-31
Completion date
2015-05-31
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Breast Neoplasms

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.

Interventions

PROCEDURESingle injection paravertebral block

The patients in single injection group will receive single injection paravertebral block at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections

PROCEDUREMultiple injection paravertebral blocks

Patients in the multiple injection group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% ropivacaine was injected at each level.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensory dermatomal spread20 minutes20 minutes after block performance

Secondary

MeasureTime frameDescription
Time to performance of procedureDuration of procedure
Cephalic and caudal dermatomal spread20 minutes after block performance
Incidence of complication24 hoursFollow-up phone call
VAS pain scores in PACU6 hoursDuring PACU stay
Duration of self-reported numbness at the surgical site24 hoursAt follow-up phone call

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026