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

NCT07800364 | Recruiting DMC

• 1 other identifier: 36264PR13101106
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Preoperative, Tizanidine,; Pain

Outcome Measures

Primary Outcomes (2)

• Time to first request of rescue analgesia

  24 hr

• opioid consumption in 48 hrs postoperatively

  48hr

Study Arms (2)

tizanidine group

EXPERIMENTAL

tizanidine

Drug: Tizanidine

placebo group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Tizanidine DRUG

oral administered preoperatively

tizanidine group

Placebo DRUG

oral placebo adminstered preoperatively

placebo group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥ 21 years
• Scheduled for lower limb orthopedic surgery
• Able to provide informed consent

You may not qualify if:

• History of hypersensitivity to tizanidine
• Pregnancy or breastfeeding
• Failure of spinal anesthesia or inadequate block.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

tanta University hospital

Tanta, Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Marwa Abogabal, Assistant professor

CONTACT

0201004190210; Dr_mora1985@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marwa Ahmed Abogabal

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 2, 2026
• Study Start: March 1, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-03

Locations

EG (1)