A Phase 4 interventional study of Paracetamol and Ibuprofen in Pain, Acute, Hip Arthropathy and Analgesia, sponsored by Naestved Hospital. Completed at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Naestved Hospital · Phase 4, Interventional, and Treatment
Multimodal pain management is essential for recovery after surgery, aiming to target different pain mechanisms to minimize opioid usage and opioid-related adverse effects. Evidence for benefits and harms of various non-opioid analgesic combinations is, however, nearly non-existing, and large-scale trials are urgently needed.
Recently, the investigators have demonstrated that combining paracetamol and ibuprofen is superior to each single drug when assessing pain after hip replacement. Further improvement is needed, investigating additional non-opioid analgesics to this combination. Glucocorticoids have anti-emetic and analgesic properties, but evidence for analgesic efficacy in combination with paracetamol and ibuprofen is lacking.
The RECIPE trial is an investigator-initiated randomized, placebo-controlled, parallel, 4-group, blinded multicentre trial with 90-day follow-up investigating benefits and harms of different combinations of paracetamol, ibuprofen, and dexamethasone for patients undergoing total hip arthroplasty.
The primary outcome is total use of IV morphine 0-24 hours postoperatively. Secondary outcomes are pain (upon mobilisation, at rest, and during 5 m walk), and adverse events. Exploratory outcomes include quality of sleep, opioid-related adverse effects, serious adverse events (\< 90 days), and patient reported disability score and quality of life (at 90 days).
Based on sample-size calculations, 1060 patients are needed to detect a minimal clinically important difference in 24-hour morphine consumption of 8 mg, using a familywise type 1 error rate of 0.05 and a type 2 error rate of 0.2. The primary analyses will be based on the intention to treat population. More than six Danish university- and regional hospitals will participate in the trial.
With this trial the investigators expect to lay the foundation for the best postoperative multimodal analgesic regimen for both total hip arthroplasty and possibly other surgeries, thereby facilitating recovery for millions of future surgical patients worldwide.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 1,060 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Naestved Hospital is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Paracetamol 1000 mg + Ibuprofen 400 mg administered orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day. Plus placebo (matching DXM) IV administered after induction of anaesthesia
Drug: Paracetamol · Drug: Ibuprofen · Drug: Placebo IV
Paracetamol 1000 mg and placebo (matching ibuprofen) orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day. Plus DXM 24 mg IV after induction of anaesthesia
Drug: Paracetamol · Drug: Dexamethasone · Drug: Placebo oral capsules
Placebo (matching paracetamol) + ibuprofen 400 mg orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day. Plus DXM 24 mg IV after induction of anaesthesia
Drug: Ibuprofen · Drug: Dexamethasone · Drug: Placebo oral capsules
Paracetamol 1000 mg + ibuprofen 400 mg orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day. Plus DXM 24 mg IV after induction of anaesthesia
Drug: Paracetamol · Drug: Ibuprofen · Drug: Dexamethasone
1g x 4 p.o.
Also known as: Acetaminophen
400mg x 4 p.o.
24mg IV x 1 after induction om anaesthesia
p.o. x 4
IV x 1
Cumulative opioid consumption in the first 24 hours after surgery
Cumulative opioid consumption in units of intravenous morphine equivalents in the first 24 postoperative hours. This includes opioids administered as (a) patient-controlled analgesia (PCA); (b) supplemental opioid administered at the post-anaesthesia care unit the first hour after end of surgery (general anaesthesia) or the first hour after ceasing of spinal anaesthesia; and (c) any supplemental opioid given at the ward
Time frame: 0-24 hours after end of surgery
Pain scores during mobilisation 24h
Pain scores (visual analogue scale (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)) with active 30 degrees flexion of the hip
Time frame: 24 hours after end of surgery
Pain scores at rest 24h
Pain scores at rest (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)
Time frame: 24 hours after end of surgery
Maximum level of pain
Maximum level of pain (VAS 0-100 mm No pain = 0; worst imaginable pain = 100) during walk of 5 meters
Time frame: 24 hours after end of surgery
Adverse events in the intervention period
Proportion of patients with one or more AEs in the intervention period
Time frame: From end of surgery + 24 hours
Serious adverse events within one year
SAEs, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except 'prolongation of hospitalisation' that has been modified to 'prolongation of hospitalization with ≥4 days'
Time frame: Within 90 days
Pain scores during mobilisation 6h
Pain scores (visual analogue scale (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)) with active 30 degrees flexion of the hip
Time frame: 6 hours after end of surgery
Pain scores at rest 6h
Pain scores at rest (VAS 0-100 mm; no pain = 0; worst imaginable pain = 100)
Time frame: 6 hours after end of surgery
Prevalence of nausea
Prevalence of nausea, 6 and 24 hours after end of surgery
Time frame: 6 and 24 hours after end of surgery
Number of vomiting episodes
The number of productive vomiting events (volume estimated over 10 ml) is recorded corresponding to the period 0-24 hours
Time frame: 0-24 after end of surgery. Reported by interview 24 hours after end of surgery
Consumption of ondansetron and dehydrobenzperidole
Consumption of ondansetron and dehydrobenzperidole in mg
Time frame: 0-24 hours after end of surgery
Incidence of dizziness during 5 meter walk
Incidence of dizziness during 5 meter walk 24 hours after surgery
Time frame: 24 hours after end of surgery
Blood loss
Blood loss in ml during the surgical procedure
Time frame: Intraoperatively
Quality of sleep
Quality of sleep (VAS 0-100 mm; worst possible sleep = 0; best possible sleep = 100) Worst possible sleep = 0; best possible sleep = 100
Time frame: 24 hours after end of surgery
Days alive and outside hospital within 90 days after surgery
Days alive and outside hospital within 90 days after surgery
Time frame: Within 90 days after surgery
Oxford Hip Score at 90 days
5-point Lipert-scale (no, mild, moderate, severe and extreme)
Time frame: At 90 days after surgery
Quality of life (EQ-5D-5L) at 90 days
EuroQol five-dimensions 5 point Lipert scale (EQ-5D-5L)
Time frame: At 90 days after surgery
Opioid use at 90 days
Consumption of opioids within 90 days after surgery
Time frame: Within 90 days after surgery
Serious adverse events within 1 year
Proportion of participants with one or more serious adverse events, including death, within one year after surgery, according to ICH-GCP guidelines\[24\] (except for 'prolongation of hospitalization' that has been modified to 'prolongation of hospitalization with ≥4 days')
Time frame: Within one year after surgery
Oxford Hip Score at one year
5-point Lipert-scale (no, mild, moderate, severe and extreme)
Time frame: One year after surgery
Quality of life (EQ-5D-5L) at one year
EuroQol five-dimensions 5 point Lipert scale (EQ-5D-5L)
Time frame: One year after surgery
Opioid use at one year
Consumption of opioids within one year after surgery
Time frame: Within one year after surgery
Ran from Mar 2020 to primary completion in Nov 2022, 32 months.
Of 79 non-industry phase 4 interventional studies under Acute Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 32. This study's 32 months is above that.
Counting every sponsor, half of 84 studies reached it within 19 months; a quarter within 9 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Acetaminophen · Ibuprofen · Dexamethasone
Naestved Hospital