Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University
About this trial
Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo.
Adult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups:
* High-dose group: intravenous paracetamol 2 g * Standard-dose group: intravenous paracetamol 1 g * Control group: intravenous normal saline placebo
Each infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 65 years
American Society of Anesthesiologists (ASA) physical status I or II
Scheduled for elective lower-limb orthopedic surgery under spinal anesthesia
Expected surgical duration between 1 and 3 hours
Disqualifiers
Patient refusal or inability to provide informed consent
ASA physical status >= III
Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at injection site, severe spinal deformity)
Known allergy or hypersensitivity to paracetamol or the local anesthetic used
Trial design
Design model
Parallel
Treatments tested in this trial
Paracetamol 2 g
DrugIntravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.
Paracetamol 1 g
DrugIntravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.
Normal Saline Placebo
DrugIntravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Group H: High-Dose Paracetamol (2 g)Experimental treatment 1 intervention
Group B: Group S: Standard-Dose Paracetamol (1 g)Active comparator 1 intervention
Group C: Group C: Placebo ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Clinically Significant Post-Spinal Shivering
Clinically significant shivering is defined as a shivering score \>= 3 on the Crossley and Mahajan Shivering Grading Scale. The scale ranges from Grade 0 to Grade 4: Grade 0 = No shivering; Grade 1 = Piloerection or peripheral vasoconstriction without visible muscular activity; Grade 2 = Muscular activity confined to one muscle group; Grade 3 = Muscular activity involving more than one muscle group, but not generalized; Grade 4 = Gross muscular activity involving the whole body. Higher grades indicate greater shivering severity.
Time frame
Up to 4 hours post-spinal injectionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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