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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800364
Acronym
Tizanidine
Enrollment
68
Registered
2026-09-02
Start date
2026-03-01
Completion date
2026-09-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Effect of Preoperative Administration of Oral Tizanidine, Post Operative Pain

Keywords

Preoperative, Tizanidine,, Pain

Brief 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

Interventions

oral administered preoperatively

DRUGPlacebo

oral placebo adminstered preoperatively

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Time to first request of rescue analgesia24 hr
opioid consumption in 48 hrs postoperatively48hr

Countries

Egypt

Contacts

CONTACTMarwa Abogabal, Assistant professor
Dr_mora1985@med.tanta.edu.eg0201004190210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026