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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480958
• Other study ID #: 2018-94
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: August 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 25-70 years of agge

• ASA I-II

• Undergoing elective breast cancer surgery

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

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Intravenous morphine patient controlled device
24 hour morphine consumption will be recorded

Other:
• Erector Spinae Plane Block
erector spinae plane block will be administered before the surgery
• Thoracic Paravertebral Block
thoracic paravertebral block will be administered before the surgery

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.	24 hour postoperatively
Secondary	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	24 hour
Secondary	Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting will be recorded	24h