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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative modified PEC block only | Active Comparator | Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon |
|
| Adding preoperative thoracic paravertebral nerve block | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic paravertebral block under ultrasound guidance | Procedure | Ultrasound-guided thoracic paravertebral blocks in T2, T4 level |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suwimon Tangwiwat, MD | Contact | 66816456167 | stangwiwat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Suwimon Tangwiwat, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30640648 | Background | Missair A, Cata JP, Votta-Velis G, Johnson M, Borgeat A, Tiouririne M, Gottumukkala V, Buggy D, Vallejo R, Marrero EB, Sessler D, Huntoon MA, Andres J, Casasola OL. Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA special article. Reg Anesth Pain Med. 2019 Jan;44(1):13-28. doi: 10.1136/rapm-2018-000001. | |
| 28820803 |
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group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
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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).
|
| Intraoperative modified PEC block | Procedure | Pectoral nerve block by surgeon under direct vision after total mastectomy |
|
|
| GA with ETT | Procedure | General anesthesia with endotracheal intubation |
|
| 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 |
| Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641. |
| 28601480 | Background | Wynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7. |
| 28890559 | Background | Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17. |
| 26431130 | Background | Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80. |
| 10825328 | Background | Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026. |
| 25376971 | Background | Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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