Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

Mastectomy Clinical Trial

Official title:

A Prospective Randomized Controlled Trial of Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02623387
• Other study ID #: UHG15
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2015
• Last updated: December 4, 2015
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: University College Hospital Galway
• Contact: Deirdre Nally, MCh
• Email: deirdrenally[@]rcsi.ie
• Is FDA regulated: No
• Health authority: Ireland: Health Service Executive
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.

Description:

Adequate pain control is important in breast cancer surgery. In addition to benefits to patients, effective pain management strategies also facilitate day case surgery. Regional anaesthetic techniques, and paravertebral blocks in particular, are valuable in this sphere. The conventional method of administering this block is blind and depends on anatomical landmarks for placement. Performing the block under US guidance provides real time imaging while advancing the needle. This might allow for a more accurate placement and hence a more effective block which would enhance pain relief and minimise complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing resectional breast surgery

• Benign or malignant indications for surgery

Exclusion Criteria:

• Previous spinal surgery

• Severe coagulopathy

• Allergies to local anaesthesia

• Localised infection at site of injection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast-Conserving Surgery
• Mastectomy
• Regional Anaesthesia

Intervention

Procedure:
• Ultrasound guided paravertebral block
Paravertebral blocks is a regional anaesthetic technique in which thoracic spinal nerves are inhibited for post operative analgesia in patients undergoing breast surgery. The site of injection can be determined using anatomical landmarks (standard) or using ultrasound guidance.

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway	Co. Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia requirements in 24 hours post op.	Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op	24hours	No
Secondary	Pain Scores	Measured on Visual Analogue Scale or Verbal Numerical Rating Scale at 1, 2 and 24 hours post operatively and 1 week	1, 2 and 24 hours post operatively and 1 week post operatively	No
Secondary	Patient satisfaction	Satisfaction Questionnaire; SF 36 Questionnaire	Up to 2 weeks post operatively	No
Secondary	Complications	Any complication of the procedure experienced	Up to 2 weeks post operatively	No