Evaluation of the added value of Metamizole to standard post-operative treatment after ambulant surgery: a double-blind, randomized controlled trial

Evaluation of the added value of Metamizole to standard post-operative treatment after ambulant surgery: a double-blind, randomized controlled trial - Metamizole trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002801-23-BE

Enrollment

110

Registered

2019-09-13

Start date

2019-10-08

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimalization of post-operative treatment after ambulant surgery

Interventions

Trade Name: Novalgine Product Name: Metamizole Pharmaceutical Form: Coated tablet INN or Proposed INN: METAMIZOLE SODIUM CAS Number: 68-89-3 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: -Quality of Recovery on baseline and at days 7, 14, 28 and 3 months postoperatively. -Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. -Simple shoulder test (SST) measured on baseline and at days 7, 14, 28 and 3 months postoperatively. -Adherence to study medication on day 1, 2, 3 and 4 postoperatively. -Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) -Total amount of intravenous piritramide received in the PACU -The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) -Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day and 3 months postoperatively by NRS. ;Primary end point(s): Postoperative pain intensity at movement measured by an 11-point Numeric Rating Scale (NRS) where 0: no pain and 10: worst imaginary pain) on postoperative day 1.;Timepoint(s) of evaluation of this end point: Post operative day 1;Main Objective: 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.	—

Measure

Time frame

Secondary Objective: -Quality of Recovery on baseline and at days 7, 14, 28 and 3 months postoperatively. -Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. -Simple shoulder test (SST) measured on baseline and at days 7, 14, 28 and 3 months postoperatively. -Adherence to study medication on day 1, 2, 3 and 4 postoperatively. -Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) -Total amount of intravenous piritramide received in the PACU -The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) -Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day and 3 months postoperatively by NRS. ;Primary end point(s): Postoperative pain intensity at movement measured by an 11-point Numeric Rating Scale (NRS) where 0: no pain and 10: worst imaginary pain) on postoperative day 1.;Timepoint(s) of evaluation of this end point: Post operative day 1;Main Objective: 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.

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Secondary

Measure	Time frame
Secondary end point(s): - Quality of Recovery measured by the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ5D) questionnaire at baseline and at day 7, 14, 28 and 3 months postoperatively. - Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. - Simple shoulder test (SST) measured at baseline and at day 7, 14, 28 and 3 months postoperatively. - Adherence to study medication on day 1, 2, 3 and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - Total amount of intravenous piritramide received in the PACU - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) - Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day and 3 months postoperatively by NRS. ;Timepoint(s) of evaluation of this end point: - Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. - Simple shoulder test (SST) measured at day 0, 2, 3, 4, 7, 14, 28 and 3 months postoperatively. - Adherence to study medication on day 1, 2, 3 and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - Total amount of intravenous piritramide received in the PACU - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) - Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day by NRS.	—

Measure

Time frame

Secondary end point(s): - Quality of Recovery measured by the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ5D) questionnaire at baseline and at day 7, 14, 28 and 3 months postoperatively. - Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. - Simple shoulder test (SST) measured at baseline and at day 7, 14, 28 and 3 months postoperatively. - Adherence to study medication on day 1, 2, 3 and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - Total amount of intravenous piritramide received in the PACU - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) - Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day and 3 months postoperatively by NRS. ;Timepoint(s) of evaluation of this end point: - Postoperative pain intensity at rest and at movement measured by NRS at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months. - Simple shoulder test (SST) measured at day 0, 2, 3, 4, 7, 14, 28 and 3 months postoperatively. - Adherence to study medication on day 1, 2, 3 and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - Total amount of intravenous piritramide received in the PACU - The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no) - Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at the seventh postoperative day by NRS.

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Countries

Belgium

Contacts

Public ContactStessel Björn

Jessa Hospital

bjorn.stessel@jessazh.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026