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Completed

NCT Number: NCT02852421

Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre University Hospital, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single injection paravertebral block

Procedure

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

Multiple injection paravertebral blocks

Procedure

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.

Primary outcomes

  1. Sensory dermatomal spread

    Time frame: 20 minutes

    20 minutes after block performance

Secondary outcomes

  1. Time to performance of procedure

    Time frame: Duration of procedure

  2. Cephalic and caudal dermatomal spread

    Time frame: 20 minutes after block performance

  3. Incidence of complication

    Time frame: 24 hours

    Follow-up phone call

  4. VAS pain scores in PACU

    Time frame: 6 hours

    During PACU stay

  5. Duration of self-reported numbness at the surgical site

    Time frame: 24 hours

    At follow-up phone call

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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