ShiveringPhase 4NCT07855575
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
A Phase 4 study testing Paracetamol 2 g and Paracetamol 1 g in people with Shivering and Postoperative Shivering, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shivering, Postoperative Shivering, Hypothermia
- What is being tested?
- Paracetamol 2 g and Paracetamol 1 g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willingness to provide written informed consent
Who cannot join
- 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
- Baseline (preoperative) core/tympanic temperature < 36.5°C or > 37.5°C
- Pre-existing hepatic, renal, or thyroid disorders
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- History of seizure disorder
- Chronic alcohol use, malnutrition, or any condition predisposing to hepatotoxicity
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or lactation
- Chronic use of antipyretic or anti-inflammatory medication within 24 hours of surgery
- Cardiac arrhythmia or hemodynamic instability
About this study
Official title: Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled 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:
Read more
- 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.
- Conditions
- Shivering, Postoperative Shivering, Hypothermia
- Being tested
- Paracetamol 2 g, Paracetamol 1 g, Normal Saline Placebo
- Keywords
- Paracetamol, Acetaminophen, Spinal Anesthesia, Lower Extremity Surgery, Orthopedic Procedures, Dose-Response Relationship, Post-Spinal Shivering, Thermoregulation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 2 gDrug
Intravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.
Paracetamol 1 gDrug
Intravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection.
Normal Saline PlaceboDrug
Intravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding.
| Study group | Role | What they receive |
|---|---|---|
| Group H: High-Dose Paracetamol (2 g) | Experimental | Patients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. Receives: Drug: Paracetamol 2 g |
| Group S: Standard-Dose Paracetamol (1 g) | Active comparator | Patients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. Receives: Drug: Paracetamol 1 g |
| Group C: Placebo Control | Placebo comparator | Patients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection. Receives: Drug: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours post-spinal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Mohamed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855575
- Sponsor's protocol ID
- Paracetamol Dose for Shivering
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855575
- Acronym / sponsor ID
- Paracetamol Dose for Shivering
- Conditions
- Shivering, Postoperative Shivering, Hypothermia
- Keywords
- Paracetamol, Acetaminophen, Spinal Anesthesia, Lower Extremity Surgery, Orthopedic Procedures, Dose-Response Relationship, Post-Spinal Shivering, Thermoregulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group H: High-Dose Paracetamol (2 g) | Experimental | Drug: Paracetamol 2 gPatients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
| Group S: Standard-Dose Paracetamol (1 g) | Active comparator | Drug: Paracetamol 1 gPatients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
| Group C: Placebo Control | Placebo comparator | Drug: Normal Saline PlaceboPatients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Willingness to provide written informed consent
Key exclusion criteria (12 listed)
- 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
- Baseline (preoperative) core/tympanic temperature < 36.5°C or > 37.5°C
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 |
|---|---|---|
| Paracetamol 2 gIntravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. | Drug | Group H: High-Dose Paracetamol (2 g) |
| Paracetamol 1 gIntravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. | Drug | Group S: Standard-Dose Paracetamol (1 g) |
| Normal Saline PlaceboIntravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding. | Drug | Group C: Placebo Control |
Primary outcome
Percentage of Participants With Clinically Significant Post-Spinal Shivering
Time frame: Up to 4 hours post-spinal injection
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.
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 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol 2 g and Paracetamol 1 g in people with Shivering and Postoperative Shivering, run by Assiut University.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinically Significant Post-Spinal Shivering (time frame: Up to 4 hours post-spinal injection). 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 Oct 2026.