Status:
COMPLETED
Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery
Lead Sponsor:
Jessa Hospital
Conditions:
Analgesia
Surgery
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 aft...
Detailed Description
Ambulant surgery has been expanding substantially in the past decade, primarily because it is associated with lower costs and it is believed to be as safe as surgery in the in-patient setting. Moreove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04082728
Start Date
November 28 2019
End Date
February 7 2022
Last Update
February 8 2022
Active Locations (1)
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1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500