Evaluation of the Added Value of Metamizole to Standard Postoperative Treatment After Ambulant Shoulder Surgery

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate if the combination of metamizole and paracetamol is superior in reducing post-operative pain on day 1 after ambulatory shoulder surgery where the use of NSAIDs is prohibited compared to paracetamol treatment.

Therefore, a monocenter, prospective, double-blind, randomized controlled superiority trial will be designed to investigate the superiority of the combination of metamizole and paracetamol compared to paracetamol treatment in patients undergoing arthroscopic shoulder surgery with tendon repair.

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

Details

• Lead Sponsor: Jessa Hospital
• Treatments: Dipyrone

Criteria

Inclusion Criteria:

• Patients aged between 18 and 75 years

• ASA classification 1, 2 or 3

• Bodyweight > 50 kg

• Undergoing ambulatory arthroscopic shoulder surgery and with a contraindication to NSAID (SAD ± ACJ excision or decompression, decompression + biceps tenodesis, SLAP repair, Bankart repair, rotator cuff repair)

Exclusion Criteria:

• Not meeting inclusion criteria

• Cognitive impairment or no understanding of the Dutch language

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

• Allergy to or contraindication for taking the study medication (e.g. paracetamol or metamizole)

• Porphyria

• Pregnancy or lactation

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

• 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