Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study

Conditions
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Breast Cancer Female, Pain, Postoperative

Intervention / Treatment
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* Procedure: Thoracic paravertebral block under ultrasound guidance
* Procedure: Intraoperative modified PEC block
* Procedure: GA with ETT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraoperative modified PEC block only<br>Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon | Procedure: Intraoperative modified PEC block<br>* Pectoral nerve block by surgeon under direct vision after total mastectomy<br>* Other names: Modified PEC block;Procedure: GA with ETT<br>* General anesthesia with endotracheal intubation<br>|
| Experimental: Adding preoperative thoracic paravertebral nerve block<br>Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon | Procedure: Thoracic paravertebral block under ultrasound guidance<br>* Ultrasound-guided thoracic paravertebral blocks in T2, T4 level<br>* Other names: USG-TPVB;Procedure: Intraoperative modified PEC block<br>* Pectoral nerve block by surgeon under direct vision after total mastectomy<br>* Other names: Modified PEC block;Procedure: GA with ETT<br>* General anesthesia with endotracheal intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative fentanyl consumption | Cumulative fentanyl consumption within postoperative 24 hours | at postoperative 24 hours | 
| Postoperative fentanyl consumption | Cumulative fentanyl consumption within postoperative 24-48 hours | at postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative fentanyl use | Dosage of intraoperative fentanyl usage in micrograms | Intraoperation | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | at postoperative 0 hour (PACU arrival) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | at postoperative 30 min (in PACU) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | at postoperative 1 hour (in PACU) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | Postoperative 6 hour (at ward) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | Postoperative 12 hour (at ward) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | Postoperative 18 hour (at ward) | 
| Postoperative pain score at rest | Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable) | Postoperative 24 hour (at ward) | 
| Postoperative pain score on shoulder movement | Numeric rating score ((0= no pain, 10= worst pain imaginable) | Postoperative 1 hour (at PACU) | 
| Postoperative pain score on shoulder movement | Numeric rating score ((0= no pain, 10= worst pain imaginable) | Postoperative first day (at ward) | 
| Postoperative pain score on shoulder movement | Numeric rating score ((0= no pain, 10= worst pain imaginable) | Postoperative second day (at ward) | 
| First time to fentanyl requirement by IV PCA | time to require fentanyl patient-controlled intravenous analgesia | Within 24 hours | 
| Percentage of patients presenting with opioid-related adverse effects | adverse effects include postoperative nausea, vomiting, dizziness, pruritus | Within 48 hours | 
| Percentage of patients presenting with nerve block complications | nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome | Within 48 hours | 
| Length of hospital stay | Number of hospital admission days | From preoperative admission until hospital discharge | 
| Patient's satisfaction scale score | Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied) | At postoperative 48 hours | 
| Cost effectiveness analysis | Cost of adding nerve block and postoperative pain score | Within 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance