Status:
COMPLETED
Evaluation of the Added Value of Metamizole to Standard Postoperative Treatment After Ambulant Shoulder Surgery
Lead Sponsor:
Jessa Hospital
Conditions:
Postoperative Pain
Analgesia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 prohib...
Detailed Description
In an ambulatory setting, good post-operative analgesia is challenging because patients have to control pain at home by themselves, in the absence of hospital staff. Moreover, there is a limit in the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04703257
Start Date
February 26 2021
End Date
December 21 2022
Last Update
January 6 2023
Active Locations (1)
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1
Anesthesiology Jessa hospital
Hasselt, Belgium, 3500