Pain
Conditions
Interventions
Trade Name: Perfalgan
Product Name: Perfalgan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Paracetamol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
Bristol-Myers Squibb SL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject is willing to participate in the study and sign the informed consent. 2) All subjects must have the ability to read and understand the study procedures and the use of the pain scales, must be able to operate a PCA device and to communicate meaningfully with the study observer and staff. 3) In-patients with ASA risk class I, II or III according to the American Society of Anaesthesiologist (Appendix 1). 4) Subjects undergoing total hip arthroplasty and prepared for PCA during the anesthetic consultation. 5) Surgery conducted under standardized spinal anesthesia and presenting a Modified Bromage Score equal to 2 (almost complete block), after arrival in the PACU. 6) Body mass index (BMI) greater than or equal to 19 and less than or equal to 35 7) Men or women (not nursing and not pregnant) at least 18 years of age but no greater than 80 years old. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. 8) Subject free of any contra-indication to the study drugs, or excipients, the rescue medication and to the standardized anesthesia protocol. 9) Subjects free of other painful physical conditions which, in the opinion of the investigator, may confound quantifying postoperative pain resulting from hip arthroplasty. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. 2) WOCBP using a prohibited contraceptive method 3) Women who are pregnant or breastfeeding. 4) Women with a positive pregnancy test on enrollment or prior to study drug administration. 5) Subject for whom the spinal anesthesia was converted to general anesthesia during the procedure. 6) Subject who needs simultaneously any additional surgery procedures unrelated to hip arthroplasty during the same session. 7) Subject scheduled for early reintervention or reinstrumentation, i.e. within 60 days of the initial procedure or less. 8) Subject with abnormally high perioperative blood loss at risk of hypovolemia during the postoperative period. 9) Subject with known or suspected history of alcohol or drug abuse. 10) Subject with psychiatric disease or medical conditions which in the opinion of the investigator may invalidate subject ability to communicate with the investigator or to comply with the study procedures. 11) Subject having a history of complete non-response to either paracetamol, NSAID’s or tramadol when seeking pain relief; subjects having previously required more than usual doses of analgesics for comparable surgical procedures. 12) Subject with any known significant medical disease(s) or condition(s) that in the investigator´s judgement could compromise the subject´s ability to communicate with the study staff or contraindicate study participation. 13) Impaired liver function (transaminases > 3 x upper limit of normal range). 14) Advanced renal dysfunction (creatinine > 2.0 mg/dL or 170 µmol/L) or subject at risk for renal failure due to volume depletion. 15) Subject with coagulation alterations. 16) Any additional laboratory abnormality which, in the investigator´s opinion would contraindicate study participation. 17) Respiratory insufficiency or severe cardiac insufficiency not stabilized by therapy. 18) Chronic malnutrition. 19) Subject with raised intracranial pressure or convulsions. 20) Known hypersensitivity or contraindications to study drugs or related compounds, rescue medication, standardized anaesthesia or to inactive ingredients of the study medication. 21) Subject who has taken NSAIDs within 8 hours (48 h for long acting NSAIDs) before administration of the study medications, any analgesic drug within the 12 hours (48 h for long acting drugs) prior to administration of the study medications or any medication that, in the opinion of the Investigator, would be expected to confound the analgesic responses. 22) Subject who is taking any concomitant treatments (i.e. sedatives, hypnotics, anxiolytics, anti-depressant drugs, tranquilizers) which could potentially confound the quantification of analgesia. 23) Subject treated with MAO inhibitors or whose treatment with these has been stopped less than 10 days prior to surgery; subject treated with corticosteroids or whose treatment with these has been stopped less than 7 days prior surgery. 24) Subject treated with agents known to affect microsomal enzymes (such as rifampicin, barbiturates, izoniazid, anticonvulsants, zidovudine, and tricyclic antidepressants), and/or agents which could affect the analgesic response (such as neuroleptic agents, clonidine and anti-psychotic agents) except as indicated in the standardized anesthesia protocol. 25) Subject treated with anticoagulants (except for heparin 5000 UI). 26) Prisoners o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of 1g of i.v. paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of PCA tramadol in the treatment of postoperative pain following total hip arthroplasty.;Secondary Objective: 1) To evaluate the analgesic efficacy of 1g of i.v. paracetamol compared to i.v. placebo, administered every 6h, as measured by pain intensity scores and pain intensity differences from baseline, cumulative doses of tramadol over each 6-hour interval, number of boluses demanded and self-administered by the subject over each 6-hour interval and over the 24-hour period, time elapsed between the first drug administration and the PCA tramadol start, total concomitant opioid use over the whole study period (72h) and subject’s global evaluation of efficacy in the treatment of postoperative pain following total hip arthroplasty over a 24-hour study period. 2) To evaluate the general safety of 1g of i.v. paracetamol compared to i.v. placebo, administered every 6h, as assessed by adverse events (AE) reporting, level of sedation, incidence of postoperative nausea and vomiting (PONV), vital signs and laboratory tests measurements in the treatment of postoperative pain.;Primary end point(s): The primary efficacy criterion will be the 24-hour cumulative dose of PCA tramadol requested over the 24-hour study period in the treatment of postoperative pain following total hip arthroplasty. Other criteria for evaluation of efficacy will include: - Cumulative doses of tramadol over the 6-hour intervals: 0h-6h, 6h-12h, 12h-18h, 18h-24h. - Number of boluses demanded and self-administered by the subjects over each 6-hour interval and over the 24-hour study period. - Time elapsed between the first study drug administration (T0) and the PCA tramadol start. - Total concomitant opioid use (whatever the type and route of administration) over the whole study period (72H). - Pain intensity scores (at rest and | — |
Countries
Spain
Outcome results
None listed