drugset / Trial / NCT07022353
Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
Effective management of postoperative pain in breast cancer surgery is essential to minimize the risk of developing postmastectomy pain syndrome.The aim of this study is to evaluate the effectiveness of combining bilevel erector spinae plane (ESP) block with a single preoperative oral dose of tizanidine in improving postoperative analgesia in patients undergoing mastectomy surgery. It is hypothesized that the combination of bilevel ESP block and single-dose oral tizanidine will provide superior postoperative analgesia compared to bilevel ESP block alone in patients undergoing mastectomy.
Timeline
- Start
- 2025-07-15
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Publications
- Background Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.
- Background 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.
- Background Mohammadi F, Marashi M, Tavakoli I, Khakbaz O. Effects of oral clonidine premedication on hemodynamic status in bimaxillary orthognathic surgery: A double-blind randomized clinical trial. J Craniomaxillofac Surg. 2016 Apr;44(4):436-9. doi: 10.1016/j.jcms.2016.01.004. Epub 2016 Jan 11.
- Background Maniker RB, Damiano J, Ivie RMJ, Pavelic M, Woodworth GE. Perioperative Breast Analgesia: a Systematic Review of the Evidence for Perioperative Analgesic Medications. Curr Pain Headache Rep. 2022 Apr;26(4):299-321. doi: 10.1007/s11916-022-01031-z. Epub 2022 Feb 23.
- Background Kurdi MS, Agrawal P, Thakkar P, Arora D, Barde SM, Eswaran K. Recent advancements in regional anaesthesia. Indian J Anaesth. 2023 Jan;67(1):63-70. doi: 10.4103/ija.ija_1021_22. Epub 2023 Jan 21.
- Background Guan HY, Yuan Y, Gao K, Luo HX. Efficacy and safety of erector spinae plane block for postoperative analgesia in breast cancer surgery-A systematic review and meta-analysis. J Surg Oncol. 2023 May;127(6):905-920. doi: 10.1002/jso.27221. Epub 2023 Feb 24.
- Background Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background Elsabeeny WY, Fahmy RM, Elshamy FH, Shehab NN, Abed SM, Taha WS, Ibrahim MA, Gad AF. Role of bilevel erector spinae with high thoracic block vs conventional unilevel block in analgesia and reduction of pain in axilla in breast cancer surgeries: a randomized controlled trial. Pain Rep. 2025 Jan 13;10(1):e1234. doi: 10.1097/PR9.0000000000001234. eCollection 2025 Feb.
- Background Dadmehr S, Shooshtari Z, Alipour M, Eshghpour M, Shaban B, Vaezi T, Samieirad S. Is Preemptive Oral Tizanidine Effective on Postoperative Pain Intensity after Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial. World J Plast Surg. 2022 Jul;11(2):37-45. doi: 10.52547/wjps.11.2.37.
- Background Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Bi-level erector spinae plane block for the control of severe back pain related to vertebral metastasis. BMJ Case Rep. 2019 Jun 20;12(6):e228129. doi: 10.1136/bcr-2018-228129.
- Background Aksu C, Kus A, Yorukoglu HU, Tor Kilic C, Gurkan Y. Analgesic effect of the bi-level injection erector spinae plane block after breast surgery: A randomized controlled trial. Agri. 2019 Jul;31(3):132-137. doi: 10.14744/agri.2019.61687.
- Background Ahiskalioglu A, Yayik AM, Oral Ahiskalioglu E, Dostbil A, Doymus O, Karadeniz E, Ari MA, Sengoz F, Alici HA, Celik EC. Ultrasound-guided bilateral superficial cervical block and preemptive single-dose oral tizanidine for post-thyroidectomy pain: a randomized-controlled double-blind study. J Anesth. 2018 Apr;32(2):219-226. doi: 10.1007/s00540-018-2468-x. Epub 2018 Feb 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tizanidine | Small molecule | 4 mg | Oral |