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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02623387
Other study ID # UHG15
Secondary ID
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


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
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