Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
NCT ID: NCT04056676
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-08-01
2022-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intraoperative modified PEC block only
Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon
Intraoperative modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
GA with ETT
General anesthesia with endotracheal intubation
Adding preoperative thoracic paravertebral nerve block
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
Thoracic paravertebral block under ultrasound guidance
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
Intraoperative modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
GA with ETT
General anesthesia with endotracheal intubation
Interventions
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Thoracic paravertebral block under ultrasound guidance
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
Intraoperative modified PEC block
Pectoral nerve block by surgeon under direct vision after total mastectomy
GA with ETT
General anesthesia with endotracheal intubation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 18-80 years old
* Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Suwimon Tangwiwat
Assistant professor, Department of Anesthesiology
Principal Investigators
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Suwimon Tangwiwat, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SI 475/2019
Identifier Type: -
Identifier Source: org_study_id
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