Evaluation of the Added Value of Metamizole to Standard Postoperative Treatment After Ambulant Shoulder Surgery

NCT04703257 | Completed

• 1 other identifier: Jessa_20.91
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 prohibited compared to paracetamol treatment. Therefore, a monocenter, prospective, double-blind, randomized controlled superiority trial will be designed to investigate the superiority of the combination of metamizole and paracetamol compared to paracetamol treatment in patients undergoing arthroscopic shoulder surgery with tendon repair.

Conditions

Postoperative Pain; Analgesia; Surgery

Keywords

ambulant shoulder surgery; post-operative pain; recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain at movement

  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 (9)

• 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 day 1, 2, 3, 4, 7, 14, 28, and 3 months postoperatively.

• 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)

Control group

PLACEBO COMPARATOR

Patients in the control group will be instructed to take a placebo tablet three times a day for four days and patients will be instructed to take 1000 mg paracetamol orally four times a day for four days.

Drug: Placebo

Intervention group

ACTIVE COMPARATOR

Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days patients will be instructed to take 1000 mg paracetamol orally four times a day for four days.

Drug: Metamizole

Interventions

Metamizole DRUG

Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days patients will be instructed to take 1000 mg paracetamol orally four times a day for four days. .

Intervention group

Placebo DRUG

Patients in the control group will be instructed to take a placebo tablet three times a day for four days and patients will be instructed to take 1000 mg paracetamol orally four times a day for four days.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Anesthesiology Jessa hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dipyrone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

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: Dr, Principal Investigator

Model Details: A monocenter, prospective, double-blind, randomized controlled superiority trial is designed to investigate the superiority of the combination of metamizole and paracetamol compared to paracetamol treatment in patients undergoing arthroscopic shoulder surgery with tendon repair.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: February 26, 2021
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)