Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery

NCT07022353 | Completed

• 1 other identifier: ESP plus oral tizanidine
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastectomy Patient

Keywords

Mastectomy; Analgesia; erector spinae plane block; tizanidine

Outcome Measures

Primary Outcomes (1)

• First analgesic request

  The time of the first analgesic request for fentanyl will be recorded.

  Up to 24 hours after the procedure.

Secondary Outcomes (5)

• Visual analogue score (VAS) for pain assessment

  Up to 24 hours after the procedure

• Total analgesic requirements of fentanyl

  Up to 24 hours after the procedure

• Heart rate (HR)

  Up to the end of the procedure

• Mean arterial blood pressure (MAP)

  Up to the end of the procedure

• Adverse effects

  Up to 24 hours after the procedure]

Study Arms (2)

Bilevel ESP block group

ACTIVE COMPARATOR

patients will have bilevel ESP block plus oral placebo capsule.

Procedure: Bilevel erector spinae plane block; Drug: Placebo Oral Capsule

Bilevel ESP block + tizanidine group

ACTIVE COMPARATOR

patients will have bilevel ESP block plus oral tizanidine capsule.

Procedure: Bilevel erector spinae plane block; Drug: tizanidine oral capsule

Interventions

Bilevel erector spinae plane block PROCEDURE

Block will be performed unilaterally with the patient in the sitting position leaning forward. The block will be done using a high frequency linear probe (6-13 MHz). The block area will be adequately sterilized and draped, then the ultrasound probe will be placed 2-3 cm laterally from the midline at the level of the T3 spinous process using a sagittal approach to identify the hyperechoic transverse process shadow deep to the trapezius, rhomboid major, and erector spinae muscles. Then, the needle will be inserted craniocaudally in-plane to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real-time visualization of 2-mL saline hydro dissection. After confirmation of needle position, 15 mL of bupivacaine 0.25% will be injected at each level. The same procedure was repeated for the second level T5 spinous process. block failure defined as the presence of full sensation after 30 minutes, patients will be excluded .

Also known as: ESP

Bilevel ESP block + tizanidine group; Bilevel ESP block group

Placebo Oral Capsule DRUG

One hour prior to anesthesia induction, the patients will recieve oral placebo capsule that will have the same color, smell, and size as tizanidine.

Also known as: Placebo

Bilevel ESP block group

tizanidine oral capsule DRUG

One hour prior to anesthesia induction, the tizanidine group will receive a 4 mg tizanidine oral capsule.

Also known as: tizanidine

Bilevel ESP block + tizanidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) ІІ patients.
• Scheduled for unilateral modified radical mastectomy.
• BMI levels between 18.5- 35 Kg/m2.

You may not qualify if:

• Patient's refusal.
• Altered mental status or un-cooperative patients.
• History of known sensitivity to the used anesthetics.
• Bleeding or coagulation diathesis.
• Infection or redness at the injection site.
• Cardiac, renal, hepatic, hematological disease, peptic ulcer, gastrointestinal bleeding, and central or peripheral neurological disease.
• Chronic pain.
• Participants used analgesics routinely within the last 24 h.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology Centre

Al Mansurah, Egypt

Location

Related Publications (12)

• 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.

  PMID: 26555871 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.

  PMID: 28820803 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.

  PMID: 26874557 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.

  PMID: 35195851 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.

  PMID: 36970484 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.

  PMID: 36826370 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.

  PMID: 27501016 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.

  PMID: 39816904 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.

  PMID: 36117905 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.

  PMID: 31227568 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.

  PMID: 31736025 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.

  PMID: 29468508 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amany H ELDeeb, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, prepare all injections and oral medication needed for the study. Another investigator blinded to the study group will give oral drug and perform block. In addition, the study subjects and the resident assessing the outcome will be blinded to the study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: July 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)