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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
Pectoral nerve block by surgeon under direct vision after total mastectomy
General anesthesia with endotracheal intubation
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
RECRUITINGPostoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24 hours
Time frame: at postoperative 24 hours
Postoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24-48 hours
Time frame: at postoperative 48 hours
Intraoperative fentanyl use
Dosage of intraoperative fentanyl usage in micrograms
Time frame: Intraoperation
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: at postoperative 0 hour (PACU arrival)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: at postoperative 30 min (in PACU)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: at postoperative 1 hour (in PACU)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: Postoperative 6 hour (at ward)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: Postoperative 12 hour (at ward)
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Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: Postoperative 18 hour (at ward)
Postoperative pain score at rest
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time frame: Postoperative 24 hour (at ward)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time frame: Postoperative 1 hour (at PACU)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time frame: Postoperative first day (at ward)
Postoperative pain score on shoulder movement
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time frame: Postoperative second day (at ward)
First time to fentanyl requirement by IV PCA
time to require fentanyl patient-controlled intravenous analgesia
Time frame: Within 24 hours
Percentage of patients presenting with opioid-related adverse effects
adverse effects include postoperative nausea, vomiting, dizziness, pruritus
Time frame: Within 48 hours
Percentage of patients presenting with nerve block complications
nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome
Time frame: Within 48 hours
Length of hospital stay
Number of hospital admission days
Time frame: From preoperative admission until hospital discharge
Patient's satisfaction scale score
Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied)
Time frame: At postoperative 48 hours
Cost effectiveness analysis
Cost of adding nerve block and postoperative pain score
Time frame: Within 48 hours