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

Not Applicable

Completed

• Conditions: Postoperative Pain; Breast Cancer
• Interventions: Device: Intravenous morphine patient controlled device; Other: Thoracic Paravertebral Block; Other: Erector Spinae Plane Block

• Registration Number: NCT03480958
• Lead Sponsor: Kocaeli University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-26
• Study Start: 2018-03-28
• Study First Posted: 2018-03-29
• Status Verified: 2018-08
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TPVB group	Intravenous morphine patient controlled device	Thoracic Paravertebral Block administered group
TPVB group	Thoracic Paravertebral Block	Thoracic Paravertebral Block administered group
ESP group	Intravenous morphine patient controlled device	Erector Spinae Plane Block administered group
Control Group	Intravenous morphine patient controlled device	No regional anesthesia technique will be applied to control group; but will be provided with iv PCA
ESP group	Erector Spinae Plane Block	Erector Spinae Plane Block administered group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Numering Rating Scale scores for pain	24 hour	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
Postoperative nausea and vomiting	24h	Incidence of postoperative nausea and vomiting will be recorded

Trial Locations

Locations (1)

Kocaeli University Hospital; 🇹🇷 Kocaeli, Turkey