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CompletedNCT03480958Updated Aug 28, 2018

Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery

An interventional study of Intravenous morphine patient controlled device and Erector Spinae Plane Block in Postoperative Pain and Breast Cancer, sponsored by Kocaeli University. Completed at 1 site in Turkey. Open to female participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by Kocaeli University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
Female
01

Study summary

Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.

02

Conditions studied

  • Postoperative Pain
  • Breast Cancer

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Keywords

  • erector spinae plane block
  • thoracic paravertebral block
  • breast surgery
  • postoperative pain
03

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 25-70 years of agge
  • ASA I-II
  • Undergoing elective breast cancer surgery

Exclusion criteria

Exclusion Criteria:

  • obesity (body mass index >35 kg/m2)
  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    ESP group

    Erector Spinae Plane Block administered group

    Device: Intravenous morphine patient controlled device · Other: Erector Spinae Plane Block

  • Active comparator
    TPVB group

    Thoracic Paravertebral Block administered group

    Device: Intravenous morphine patient controlled device · Other: Thoracic Paravertebral Block

  • Other
    Control Group

    No regional anesthesia technique will be applied to control group; but will be provided with iv PCA

    Device: Intravenous morphine patient controlled device

Interventions

  • DeviceIntravenous morphine patient controlled device

    24 hour morphine consumption will be recorded

  • OtherErector Spinae Plane Block

    erector spinae plane block will be administered before the surgery

  • OtherThoracic Paravertebral Block

    thoracic paravertebral block will be administered before the surgery

05

What researchers measure

Primary outcomes

  1. Morphine consumption

    All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.

    Time frame: 24 hour postoperatively

Secondary outcomes

  1. Numering Rating Scale scores for pain

    Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain

    Time frame: 24 hour

  2. Postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting will be recorded

    Time frame: 24h

06

Study locations

1 site
  • Kocaeli University Hospital
    Kocaeli, 41340, Turkey
07

References and documents

Publications

  • Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. PubMed 31280100 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03480958
Lead sponsor
Kocaeli University
Responsible party
Yavuz Gurkan (Professor, Kocaeli University) — Principal investigator
First posted
Mar 29, 2018
Start date
Mar 28, 2018
Primary completion
Aug 20, 2018
Completion
Aug 20, 2018
Last update
Aug 28, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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