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

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

July 15, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

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.

Trial Locations (1)

Unknown

RECRUITING

Oncology Centre, Al Mansurah

All Listed Sponsors
lead

Mansoura University

OTHER

NCT07022353 - Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery | Biotech Hunter | Biotech Hunter