reduction in pain after surgery by giving N-Acetylcysteïne before surgery

Phase 1

• Conditions: postoperative pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-003144-36-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-19
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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
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 month of planned surgery)
- Alcoholism
- Diabetes Mellitus
- Asthma or Chronic Obstructive Pulmonary Disease
- Known renal function disorders (MDRD <60)
- Known liver failure (bilirubine >1.5x upper limit of normal)
- No written IC by patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified