PainPhase 4PPPPNCT02425254
Preemptive Paracetamol for Postoperative Pain
A Phase 4 study testing Intravenous paracetamol and Intravenous saline 0.9% in people with Pain and Surgical Wound, run by University of Nottingham.
Trial summary
The purpose of this study is to test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and analgesic consumption in cervical spine surgery versus a dose given at the end of surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Surgical Wound
- What is being tested?
- Intravenous paracetamol and Intravenous saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years old
- Patients listed for non-malignant cervical spinal surgery
- General anaesthesia
- Capacity to give informed consent
- Ability to use PCA device and pain score scale
- ASA I, II and III
- >50kg in weight
Who cannot join
- Allergy or sensitivity to paracetamol, proparacetamol or morphine
- Liver disease
- Renal disease (creatinine clearance <30ml/min)
- Bleeding disorder
- Chronic alcoholism
- Chronic malnutrition
Show all 11Show fewer
- Dehydration
- G6PD deficiency
- Hypernatraemia (Na >150)
- Hypokalaemia (K <3.5) and hyperchloraemia
- Pregnancy or breast-feeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial
The purpose of this study is to test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and analgesic consumption in cervical spine surgery versus a dose given at the end of surgery.
- Conditions
- Pain, Surgical Wound
- Being tested
- Intravenous paracetamol, Intravenous saline 0.9%
- Medical subject headings
- Pain, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous paracetamolDrug
1000mg intravenous solution for infusion
Intravenous saline 0.9%Drug
0.9% sodium chloride in order to ensure double-blinding
| Study group | Role | What they receive |
|---|---|---|
| Preemptive paracetamol | Experimental | 1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery Receives: Drug: Intravenous paracetamol; Drug: Intravenous saline 0.9% |
| Postincision paracetamol | Active comparator | Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery Receives: Drug: Intravenous paracetamol; Drug: Intravenous saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured from PCA machine
Measured: 24 hours postoperatively
Secondary outcomes (11)
Time to first analgesic request
In minutes
Measured: 24 hours
Nausea and vomiting
Incidence of nausea or vomiting 24 hours postoperatively
Measured: 24 hours
Pruritus
Incidence of pruritus 24 hours postoperatively
Measured: 24 hours
Sedation
Incidence of sedation 24 hours postoperatively
Measured: 24 hours
Urinary retention
Incidence of urinary retention 24 hours postoperatively
Measured: 24 hours
Allergic reaction
Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)
Measured: 24 hours
Pain score
Numeric rating scale (NRS)
Measured: 1 hour
Pain score
Numeric rating scale (NRS)
Measured: 2 hours
Pain score
Numeric rating scale (NRS)
Measured: 6 hours
Pain score
Numeric rating scale (NRS)
Measured: 12 hours
Pain score
Numeric rating scale (NRS)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Williams, Principal investigator, University of Nottiongham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425254
- Sponsor's protocol ID
- 15029
- Acronym
- PPPP
- Status last verified
- Dec 2015
- First submitted
- 9 Apr 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial
- ClinicalTrials.gov ID
- NCT02425254
- Acronym / sponsor ID
- PPPP / 15029
- Conditions
- Pain, Surgical Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 23 Apr 2015 (estimated)
- 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 purpose of this study is to test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and analgesic consumption in cervical spine surgery versus a dose given at the end of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preemptive paracetamol | Experimental | Drug: Intravenous paracetamol, Drug: Intravenous saline 0.9%1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery |
| Postincision paracetamol | Active comparator | Drug: Intravenous paracetamol, Drug: Intravenous saline 0.9%Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-80 years old
- Patients listed for non-malignant cervical spinal surgery
- General anaesthesia
- Capacity to give informed consent
- Ability to use PCA device and pain score scale
Key exclusion criteria (11 listed)
- Allergy or sensitivity to paracetamol, proparacetamol or morphine
- Liver disease
- Renal disease (creatinine clearance <30ml/min)
- Bleeding disorder
- Chronic alcoholism
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 |
|---|---|---|
| Intravenous paracetamol1000mg intravenous solution for infusion | Drug | Postincision paracetamol, Preemptive paracetamol |
| Intravenous saline 0.9%0.9% sodium chloride in order to ensure double-blinding | Drug | Postincision paracetamol, Preemptive paracetamol |
Primary outcome
Morphine consumption
Time frame: 24 hours postoperatively
Measured from PCA machine
11 secondary outcomes
Time to first analgesic request
Time frame: 24 hours
Nausea and vomiting
Time frame: 24 hours
Pruritus
Time frame: 24 hours
Sedation
Time frame: 24 hours
Urinary retention
Time frame: 24 hours
Allergic reaction
Time frame: 24 hours
Pain score
Time frame: 1 hour
Pain score
Time frame: 2 hours
Pain score
Time frame: 6 hours
Pain score
Time frame: 12 hours
Pain score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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. This study is not recruiting at the moment.
John Williams principal investigator
University of Nottiongham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous paracetamol and Intravenous saline 0.9% in people with Pain and Surgical Wound, run by University of Nottingham.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Dec 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Williams, PhD (01332 724641, john.williams7@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 24 hours postoperatively). 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 3 Dec 2015.