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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥ 21 years

Scheduled for lower limb orthopedic surgery

Able to provide informed consent

Disqualifiers

History of hypersensitivity to tizanidine

Pregnancy or breastfeeding

Failure of spinal anesthesia or inadequate block.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tizanidine

    Drug

    oral administered preoperatively

  • Placebo

    Drug

    oral placebo adminstered preoperatively

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: tizanidine groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first request of rescue analgesia

Time frame
24 hr
2

opioid consumption in 48 hrs postoperatively

Time frame
48hr

Secondary outcomes

Other outcomes

Sponsors and contacts

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