postoperative pain
Conditions
Interventions
Trade Name: acetylcysteine
Product Name: Acetylcysteine
Product Code: RVG 10903
Pharmaceutical Form: Infusion
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intra
Sponsors
Radboud University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects scheduled for laparoscopic unilateral inguinal hernia repair. - ASA 1 or 2. - Age >18 years. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnancy or lactating - Allergy to NAC - History of chronic pain - Use of opioids or neuropathic analgesics - Use of NAC prior to trial (1.5x upper limit of normal) - No written IC by patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intravenous N-Acetylcysteine in comparison with placebo in terms of pain relief after unilateral inguinal hernia repair measured by a visual analogue scale (VAS 0-100) at day 1 after surgery;Secondary Objective: Secondary Objective(s): 1. Difference in pain scores between NAC and placebo direct after surgery, before discharge and in following 3 days postoperative. 2. Difference in time before first pain medication is administered postoperative between NAC and placebo. 3. Difference in total consumption of opiates in the hospital (mg) between NAC and placebo. 4. Difference in time from surgery to discharge between NAC and placebo. 5. Difference in postoperative pain medication at home necessary to reach adequate pain relief between NAC and placebo ( Acetaminophen /NSAID's/opiates). 6. If there is a difference in 5, is there also a difference in adverse effects of pain medication (like nausea, obstipation) between NAC and placebo.;Primary end point(s): Primary objective is to evaluate the efficacy of intravenous NAC in comparison with placebo in terms of pain relief after unilateral inguinal hernia repair measured by a visual analogue scale (VAS 0-100) at day 1 after surgery.;Timepoint(s) of evaluation of this end point: 1 day after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Pain scores (VAS 1-100) direct postoperatively , before discharge and in following 3 days postoperative. • Time to first necessity of pain medication after surgery (in minutes). • Total consumption of in hospital opiates (in mg). • Time to discharge (in minutes). • Analgesic medication taken at home by patient (registered by patients in diary) (in mg). • Adverse effect of analgesic medication (nausea, obstipation, sedation) (in numbers).;Timepoint(s) of evaluation of this end point: on the day of surgery and the 3 following days | — |
Countries
Netherlands
Contacts
Public ContactHead of department Anesthesiology
Radboud UMC
Outcome results
None listed