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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07800364
- Acronym / sponsor ID
- Tizanidine / 36264PR13101106
- Keywords
- Preoperative, Tizanidine,, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tizanidine group | Experimental | Drug: Tizanidinetizanidine |
| placebo group | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥ 21 years
Key exclusion criteria (3 listed)
- History of hypersensitivity to tizanidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tizanidineoral administered preoperatively | Drug | tizanidine group |
| Placebooral placebo adminstered preoperatively | Drug | placebo group |
Primary outcome
Time to first request of rescue analgesia
Time frame: 24 hr
opioid consumption in 48 hrs postoperatively
Time frame: 48hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Abogabal, Assistant professor (0201004190210, Dr_mora1985@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first request of rescue analgesia (time frame: 24 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.