Regional Anaesthesia, Mastectomy, Breast-Conserving Surgery
Conditions
Keywords
paravertebral block
Brief 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.
Detailed 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.
Interventions
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.
Sponsors
University College Hospital Galway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia requirements in 24 hours post op. | 24hours | Non opiate and opiate analgesia (morphine equivalent) intake at 24hours post op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 1, 2 and 24 hours post operatively and 1 week post operatively | Measured on Visual Analogue Scale or Verbal Numerical Rating Scale at 1, 2 and 24 hours post operatively and 1 week |
| Patient satisfaction | Up to 2 weeks post operatively | 1. Satisfaction Questionnaire 2. SF 36 Questionnaire |
| Complications | Up to 2 weeks post operatively | Any complication of the procedure experienced |
Countries
Ireland
Contacts
Primary ContactDeirdre Nally, MCh
Outcome results
None listed