The Effect of Preoperative Administration of Oral Tizanidine on the Postoperative Pain and Sleep Quality

NCT07800364 — Not applicable, Recruiting, 68 participants, Tanta University

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The Effect of Preoperative Administration of Oral Tizanidine on the Postoperative Pain and Sleep Quality in Patients Undergoing Lower Limb Orthopedic Surgery: A Randomized Placebo Controlled Study

Registry	NCT07800364, acronym Tizanidine
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	68 (Estimated)
Sponsor	Tanta University (Other)
Conditions	The Effect of Preoperative Administration of Oral Tizanidine, Post Operative Pain
Interventions	Tizanidine, Placebo (Drug)
Dates	start 2026-03-01, primary completion 2026-09-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-09-02, last updated 2026-09-02
Locations	1 site in Egypt

-Summary

The majority of lower limb fractures treated with surgery often leading to significant morbidity and mortality. Despite improvements in perioperative care, about 20% suffer from severe postoperative complications. So, effective perioperative pain management is crucial in this demographic to ensure optimal recovery and reduce complications. (1) Controlling the postoperative pain often begins in recovery room by using opioids, especially morphine. However, systemic opioids may develop many complications such as nausea and vomiting, apnea, respiratory depression, and urinary retention. To reduce the complications and consumption of the opioids, other procedures are recommended. One of these procedures is preemptive analgesia(2).

In addition to pain, disrupted sleep quality is a common challenge, with evidence suggesting a bidirectional relationship where poor sleep exacerbates pain, and pain further disrupts sleep (3). Addressing both pain and sleep disturbances in the perioperative period is therefore critical for enhancing recovery and improving overall patient outcomes

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+Arms and interventions

Arm	Type	Interventions	Description
tizanidine group	Experimental	Drug: Tizanidine	tizanidine
placebo group	Placebo comparator	Drug: Placebo	placebo

Tizanidine (Drug): oral administered preoperatively
Placebo (Drug): oral placebo adminstered preoperatively

+Outcome measures

Primary outcomes

Time to first request of rescue analgesia [24 hr]
opioid consumption in 48 hrs postoperatively [48hr]

+Eligibility

Sex: All, ages: 21 Years to any

Inclusion Criteria:

* Adults aged ≥ 21 years

  * Scheduled for lower limb orthopedic surgery
  * Able to provide informed consent

Exclusion Criteria:

* History of hypersensitivity to tizanidine

  * Pregnancy or breastfeeding
  * Failure of spinal anesthesia or inadequate block.

+Locations (1)

Facility	City	Country	Status
tanta University hospital	Tanta, Gharbia Governorate	Egypt	Recruiting