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NCT Number: NCT07800364

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

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

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

tanta University hospital

Tanta, Gharbia Governorate, Egypt

Location status: Recruiting

Location contact

marwa ahmed Abogabal, PhD

CONTACT

[email protected]

+201004190210

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tizanidine

Drug

oral administered preoperatively

Placebo

Drug

oral placebo adminstered preoperatively

Primary outcomes

  1. Time to first request of rescue analgesia

    Time frame: 24 hr

  2. opioid consumption in 48 hrs postoperatively

    Time frame: 48hr

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Abogabal, Assistant professor

CONTACT

[email protected]

0201004190210

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: Tizanidine

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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