Breast Cancer Female, Pain, Postoperative
Conditions
Keywords
Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance
Brief summary
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.
Detailed description
Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique. This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.
Interventions
PROCEDUREThoracic paravertebral block under ultrasound guidance
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
PROCEDUREIntraoperative modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
PROCEDUREGA with ETT
General anesthesia with endotracheal intubation
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Randomized group of patient is identified and sealed in envelope. There is not written group in anesthetic record. Postoperative outcomes are assessed by Acute Pain Service nurse or a resident (co-investigator who blinds to the technique).
Intervention model description
group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) grade I-III * Aged ≥ 18-80 years old * Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection
Exclusion criteria
* Patient refusal * Language barrier or inability to communicate with the operating team * Allergy to local anesthetic * Bleeding disorder * Previous breast surgery or thoracic radiation therapy * BMI ≥ 30 * Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication * Chronic pain patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative fentanyl consumption | at postoperative 24 hours | Cumulative fentanyl consumption within postoperative 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at rest | at postoperative 0 hour (PACU arrival) | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) |
| Postoperative pain score on shoulder movement | Postoperative 1 hour (at PACU) | Numeric rating score ((0= no pain, 10= worst pain imaginable) |
| First time to fentanyl requirement by IV PCA | Within 24 hours | time to require fentanyl patient-controlled intravenous analgesia |
| Percentage of patients presenting with opioid-related adverse effects | Within 48 hours | adverse effects include postoperative nausea, vomiting, dizziness, pruritus |
| Intraoperative fentanyl use | Intraoperation | Dosage of intraoperative fentanyl usage in micrograms |
| Length of hospital stay | From preoperative admission until hospital discharge | Number of hospital admission days |
| Patient's satisfaction scale score | At postoperative 48 hours | Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied) |
| Cost effectiveness analysis | Within 48 hours | Cost of adding nerve block and postoperative pain score |
| Percentage of patients presenting with nerve block complications | Within 48 hours | nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome |
Countries
Thailand
Contacts
Primary ContactSuwimon Tangwiwat, MD
Outcome results
None listed