Evaluation of Metamizole to standard postoperative treatment after ambulant shoulder surgery

Evaluation of the added value of Metamizole to standard postoperative treatment after ambulant shoulder surgery: a double-blind, randomized controlled trial - Metamizole003

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004237-21-BE

Enrollment

110

Registered

2020-11-03

Start date

2020-11-27

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

Optimalisation of postoperative treatment after ambulant shoulder arthroscopy

Interventions

Trade Name: Novalgine Product Name: Metamizole Pharmaceutical Form: Coated tablet INN or Proposed INN: METAMIZOLE CAS Number: 50567-35-6 Current Sponsor code: Sanofi Other descriptive name: Novalgin

Eligibility

Sex/Gender

All

Inclusion 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) 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: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: -Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively. -Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. -Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively -A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. -Adherence to study medication on days 1, 2, 3, and 4 postoperatively. -Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) -The 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 day 7 and 3 months postoperative 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: Postoperative day 1	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: -Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively. -Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. -Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively -A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. -Adherence to study medication on days 1, 2, 3, and 4 postoperatively. -Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) -The 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 day 7 and 3 months postoperative 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: Postoperative day 1

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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 days 7, 14, 28, and 3 months postoperatively. - Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. - Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively, with 0 indicating none, 1 indicating slight, 2 indicating moderate, 3 indicating substantial and 4 indicating complete pain relief. - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. - Adherence to study medication on days 1, 2, 3, and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - The 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 day 7 and 3 months postoperative by NRS. ;Timepoint(s) of evaluation of this end point: - Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively. - Postoperative pain intensity at rest and movement and total pain relief at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. - Adherence to study medication on days 1, 2, 3, and 4 postoperatively. - Adverse effects of the study medication - The 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 - Satisfaction with study medication, surgery, and hospital care and telephone follow-up measured at day 7 and 3 months postoperative 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 days 7, 14, 28, and 3 months postoperatively. - Postoperative pain intensity at rest and movement measured by NRS at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. - Total pain relief was evaluated at day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively, with 0 indicating none, 1 indicating slight, 2 indicating moderate, 3 indicating substantial and 4 indicating complete pain relief. - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. - Adherence to study medication on days 1, 2, 3, and 4 postoperatively. - Adverse effects of the study medication (i.e. pyrosis, signs of agranulocytosis or thrombocytopenia) - The 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 day 7 and 3 months postoperative by NRS. ;Timepoint(s) of evaluation of this end point: - Quality of Recovery at baseline and days 7, 14, 28, and 3 months postoperatively. - Postoperative pain intensity at rest and movement and total pain relief at baseline, at discharge, and day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively. - A simple shoulder test (SST) was measured at baseline and days 7, 14, 28, and 3 months postoperatively. - Adherence to study medication on days 1, 2, 3, and 4 postoperatively. - Adverse effects of the study medication - The 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 - Satisfaction with study medication, surgery, and hospital care and telephone follow-up measured at day 7 and 3 months postoperative 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