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Pilot study: postoperative pain reduction by pre emptive N-Acetylcysteine

Pilot study: postoperative pain reduction by pre emptive N-Acetylcysteine - NAC.TEP16

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45293
Enrollment
60
Registered
2017-09-20
Start date
2017-11-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pijngeneeskunde postoperative pain after inguinal hernia repair

Interventions

The following NAC infusion regimen will be conducted. One hour prior to surgery, the patients will receive 150 mg/kg in 200 ml intravenous bolus over 15 minutes. During NAC infusion, patients vital
inguinal hernia
N-Acetylcysteïne
pain
postoperative

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: subjects ASA 1-2 sceduled for laparoscopic inguinal hernia repair

Exclusion criteria

Exclusion criteria: - 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

MeasureTime frame
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.

Secondary

MeasureTime frame
* 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).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)