Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery

NCT04082728 | Completed DMC

• 1 other identifier: Metamizole002
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 after ambulatory surgery compared to the standard post-operative treatment. Therefore, a mono-center, prospective, double-blind, randomized controlled superiority trail will be designed in order to investigate superiority of metamizole compared to the standard post-operative treatment in patients undergoing arthroscopic shoulder surgery.

Conditions

Analgesia; Surgery; Recovery

Keywords

ambulant surgery; post-operative medication; recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain on day 1

  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.

  24 hours after the surgery

Secondary Outcomes (8)

• Quality of recovery

  at baseline and days 7, 14, 28 and 3 months postoperatively.

• Quality of recovery

  at baseline and days 7, 14, 28 and 3 months postoperatively.

• Postoperative pain

  at baseline, at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months after surgery

• Simple Shoulder test

  at baseline and days 7, 14, 28 and 3 months postoperatively.

• Adherence

  day 1, 2, 3 and 4 postoperatively.

Study Arms (2)

Metamizole

ACTIVE COMPARATOR

Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days, ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.

Drug: Metamizole

Placebo

PLACEBO COMPARATOR

Patients in the experimental group will be instructed to take a placebo orally three times a day for four days, ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.

Drug: Placebo oral tablet

Interventions

Metamizole DRUG

Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days. All patients will be instructed to take ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.

Metamizole

Placebo oral tablet DRUG

Patients in the placebo group will be instructed to take a placebo orally three times a day for four days. All patients will be instructed to take ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

• Stessel B, Lambrechts M, Evers S, Vanderstappen C, Callebaut I, Ory JP, Herbots J, Dreesen I, Vaninbroukx M, Van de Velde M. Additive or synergistic analgesic effect of metamizole on standard pain treatment at home after arthroscopic shoulder surgery: A randomised controlled superiority trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):171-178. doi: 10.1097/EJA.0000000000001792. Epub 2023 Jan 11.

  PMID: 36632758 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dipyrone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD, PhD

Model Details: This trial is designed as a mono-center, prospective, double-blind, randomized placebo controlled superiority trial comparing 2 groups of patients

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 9, 2019
• Study Start: November 28, 2019
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)