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

NCT07022353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-27

No results posted yet for this study

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

Interventions

PROCEDURE

Bilevel erector spinae plane block

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 .

DRUG

Placebo Oral Capsule

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

DRUG

tizanidine oral capsule

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Amany H ELDeeb, MD · Faculty of Medicine, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022353 on ClinicalTrials.gov