Pain after ambulatory surgery
Conditions
Interventions
Trade Name: Novalgine
Product Name: Metamizole
Pharmaceutical Form: Coated tablet
Trade Name: Brufen
Product Name: Ibuprofen
Pharmaceutical Form: Coated tablet
Sponsors
JESSA Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged between 18 and 70 years - ASA classification 1,2 or 3 - one of the following ambulatory surgical procedures: - anal surgery (anal fissura or haemmorrhoids) - arthroscopy knee - arthroscopy shoulder with interscalenus block - inguinal hernia repair 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: not meeting inclusion criteria, cognitive impairment or no understanding of the dutch language, preoperative pharmacologic pain treatment with opioids, chronic pain (fibromyalgia, CRPS, etc), allergy to or a contraindication for taking the study medication (e.g. paracetamol, metamizole, ibuprofen or another NSAID), porphyria, pregnancy, lactation, history of severe renal, hepatic, pulmonary, or cardiac failure, current symptoms or history of gastrointestinal bleeding, ileus, chronic obstipation, history of substance abuse, or use of medication with a suppressive effect on the central nervous system, hypotension, hematological disaese, use of anti-rheumatic drugs, rhinosinusitis or nasal polyposis, Glucose-6-phosphate dehydrogenase deficiency, fever or other signs of infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was twofold: 1)to assess and compare the analgesic efficacy of a combination of metamizol and paracetamol with our current pain protocol (a combination of paracetamol and ibuprofen) in the treatment of acute postoperative pain at home after painful day-case surgery. We hypothesized that ambulatory patients postoperatively treated with metamizol/paracetamol would achieve equal or even better pain relief compared to patients treated with ibuprofen/paracetamol. 2)To assess and compare recovery profile of two the study groups ;Secondary Objective: - to assess adverse effects of study medication - to assess compliance with study medication - to assess use of rescue medication - to assess satisfaction with study medication - to assess predictors of postoperative pain and poor recovery ;Primary end point(s): •Postoperative pain intensity measured by Numerical Rating Score (NRS): is there a difference in postoperative pain intensitiy between the two study groups? A small difference of more than 1 point (on NRS) is deliberately considered clinically relevant, since we make use of a non-inferiority design. •Postoperative quality of recovery, measured by three tools: oGlobal Surgical Recovery (GSR) oEQ-5D (an instrument to measure quality of life) oFunctional Recovery Index (FRI) -> Is there a difference in quality of recovery between the two study groups? ;Timepoint(s) of evaluation of this end point: Pain intensity will be assessed at movement and at rest by NRS pre-operatively (baseline) and postoperatively in the postanesthetic care unit (PACU) and in the surgical holding area before discharge (day 0). After discharge postoperative pain intensity at rest and at movement will be assessed by NRS one time a day using a diary for up to 96 hours after surgery (day 1,2,3,4), and also at one week (day 7), two weeks (day 14) and one month (day 28) after surgery. For quality of recovery, a baseline measurement of EQ-5D and | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - to assess adverse effects of study medication: PONV, micturition problems, pyrosis, constipation, abdominal complaints, signs of agranulocytosis or thrombocytopenia, etc. - to assess compliance with study medication by checking whether patients used the study medication as prescribed and the use of other pain medication - to assess use of rescue medication: amount of iv piritramide applied at the PACU and amount of tramadol taken at home - to assess patient satisfaction with study medication by an 11-point numeric scale - to assess predictors of postoperative pain and poor recovery ;Timepoint(s) of evaluation of this end point: - adverse effects of study medication: postoperative day 0,1,2,3,4,7,14,28 - compliance with study medication: postoperative day 0,1,2,3,4 - use of rescue medication: postoperative day 0,1,2,3,4 - patient satisfaction with study medication: postoperative day 7 - to assess predictors of postoperative pain: postoperative day 0,1,2,3,4 - to assess predictors of poor recovery: postoperative day 4,7,14,28 | — |
Countries
Belgium
Contacts
Public ContactStessel Björn
JESSA Hospital
Outcome results
None listed