Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate if the addition of metamizole to the standard post-operative treatment, i.e. paracetamol and ibuprofen, is superior in reducing post-operative pain on day 1 after ambulatory surgery compared to the standard post-operative treatment.

Therefore, a mono-center, prospective, double-blind, randomized controlled superiority trail will be designed in order to investigate superiority of metamizole compared to the standard post-operative treatment in patients undergoing arthroscopic shoulder surgery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jessa Hospital
• Treatments: Acetaminophen; Dipyrone; Ibuprofen

Criteria

Inclusion Criteria:

• Patients aged between 18 and 70 years

• ASA classification 1,2 or 3

• Body weight > 50 kg

• Undergoing ambulatory arthroscopic shoulder surgery (SAD ± ACJ excision or decompression, decompression + biceps tenodesis, rotator cuff repair, rotator cuff repair + decompression (+ biceps tenodesis)

Exclusion Criteria:

• Not meeting inclusion criteria

• Patients undergoing SLAP of Bankart repair

• Cognitive impairment or no understanding of the Dutch language

• Preoperative pharmacological pain treatment and/or a history of chronic pain

• Allergy to or contraindication for taking the study medication (e.g. paracetamol, metamizole, ibuprofen or another non-steroidal anti-inflammatory drug)

• Porphyria

• Pregnancy or lactation

• A history of severe renal, hepatic, pulmonary or cardiac failure

• Current symptoms or a history of gastrointestinal bleeding

• Ileus or chronic obstipation

• A history of substance abuse, or use of medication with a suppressive effect on the central nervous system

• Hypotension

• Hematological disease

• Use of anti-rheumatic drugs

• Rhinosinusitis or nasal polyposis

• Glucose-6-phosphate dehydrogenase deficiency

• Fever or other signs of infection

• Refusal of an interscalene block