The Effect of Preoperative Administration of Oral TizanidineTizanidineNCT07800364
The Effect of Preoperative Administration of Oral Tizanidine on the Postoperative Pain and Sleep Quality
A study testing Tizanidine in people with The Effect of Preoperative Administration of Oral Tizanidine and Post Operative Pain, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- The Effect of Preoperative Administration of Oral Tizanidine, Post Operative Pain
- What is being tested?
- Tizanidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 21 years
- Scheduled for lower limb orthopedic surgery
- Able to provide informed consent
Who cannot join
- History of hypersensitivity to tizanidine
- Pregnancy or breastfeeding
- Failure of spinal anesthesia or inadequate block.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
tanta University hospital
Tanta, Gharbia Governorate
marwa ahmed Abogabal, PhD, +201004190210, dr_mora1985@med.tanta.edu.eg
About this study
Official 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
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
- Being tested
- Tizanidine, Placebo
- Keywords
- Preoperative, Tizanidine,, Pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TizanidineDrug
oral administered preoperatively
PlaceboDrug
oral placebo adminstered preoperatively
| Study group | Role | What they receive |
|---|---|---|
| tizanidine group | Experimental | tizanidine Receives: Drug: Tizanidine |
| placebo group | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first request of rescue analgesia
Measured: 24 hr
opioid consumption in 48 hrs postoperatively
Measured: 48hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of Preoperative Administration of Oral TizanidineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Abogabal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800364
- Sponsor's protocol ID
- 36264PR13101106
- Acronym
- Tizanidine
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No