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

Phase 4

Completed

• Conditions: Pijngeneeskunde; postoperative pain after inguinal hernia repair

• Registration Number: NL-OMON45293
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-29
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

subjects ASA 1-2 sceduled for laparoscopic inguinal hernia repair

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 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective is to evaluate the efficacy of intravenous NAC in comparison<br /><br>with placebo in terms of pain relief after unilateral inguinal hernia repair<br /><br>measured by a visual analogue scale (VAS 0-100) at day 1 after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Pain scores (VAS 1-100) direct postoperatively , before discharge and in<br /><br>following 3 days postoperative.<br /><br>* Time to first necessity of pain medication after surgery (in minutes).<br /><br>* Total consumption of in hospital opiates (in mg).<br /><br>* Time to discharge (in minutes).<br /><br>* Analgesic medication taken at home by patient (registered by patients in<br /><br>diary) (in mg).<br /><br>* Adverse effect of analgesic medication (nausea, obstipation, sedation) (in<br /><br>numbers).</p><br>