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Completed

NCT Number: NCT04082728

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

About this study

Ambulant surgery has been expanding substantially in the past decade, primarily because it is associated with lower costs and it is believed to be as safe as surgery in the in-patient setting. Moreover, it seems that early discharge can contribute to a faster recovery and a decreased incidence of hospital-associated complications. In view of the relative absence of major complications, post-operative pain and quality of recovery should be considered the principal endpoints after day surgery. The quality of recovery after different types of surgery is of major importance since the evaluation of recovery allows a discrimination between a normal and pathological health trajectory. A disadvantage in the ambulatory setting is related to the absence of postoperative surveillance by professionals. This implicates that the individual patient has to assess, without any support, if his/her quality of recovery is normal or not. There is limited information on procedure-specific quality of recovery after day surgery, however, different tools such as the 1-tem Global Surgical Recovery (GSR) index and the 5-dimensional European Quality of Life (EQ5D) questionnaires can be addressed.

Particularly in the ambulant 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 type of analgesia that is available (i.e. no strong opioids) as well as in the route of administration (i.e. no epidural, intravenous, subcutaneous or intramuscular route) at home. Nowadays a multimodal approach to control pain has been advocated in the ambulatory setting. This approach is based on a combination of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and, if necessary, weak opioids. A local and regional anesthesia also have been advocated in the ambulatory setting to relieve pain for 8 to 24 hours after surgery. Despite this multimodal pain therapy, the prevalence of outpatients suffering moderate to severe acute postoperative pain at home still remains high and varies from 9 to 40%. More specific, patients undergoing haemorrhoid surgery, arthroscopic shoulder and knee surgery, and inguinal hernia repair seem to be at highest risk to develop moderate to severe pain on the fourth postoperative day.

Due to this relatively high prevalence and due to the fact that NSAIDs are not always sufficiently effective, can have numerous contraindications and therefore are not suitable in up to 25% of all patients; there is a need for an alternative pain therapy.

Metamizole (dipyrone) is a non-opioid compound with strong analgesic, antipyretic and spasmolytic effects. The analgesic efficacy of intravenous or intramuscular metamizole for pain relief after inpatient surgery is well described. Recently, we showed in a prospective, double-blind, randomized controlled trial that the combination of paracetamol and metamizole is equally effective in treatment of acute post-operative pain at home after ambulatory surgery compared to paracetamol and ibuprofen. Moreover, patient satisfaction was equal in both groups, as well as the reported side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • Not meeting inclusion 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative pain on day 1

    Time frame: 24 hours after the surgery

    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.

Secondary outcomes

  1. Quality of recovery

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

    Quality of Recovery measured by the 1-item Global Surgical Recovery (GSR) index which represents a single question about the extent to which patients consider themselves to be recovered from surgery (0-100%) at baseline and days 7, 14, 28 and 3 months postoperatively.

  2. Quality of recovery

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

    Measured with the EuroQol (EQ5D) questionnaire, which is non-disease specific instrument developed for describing and valuing health-related quality of life, at baseline and days 7, 14, 28 and 3 months postoperatively.

  3. Postoperative pain

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

    Postoperative pain intensity at rest and at movement measured by an 11-point Numeric Rating Scale (NRS) where 0: no pain and 10: worst imaginary pain) at baseline, at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months.

  4. Simple Shoulder test

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

    Simple shoulder test (SST) measured at baseline and days 7, 14, 28 and 3 months postoperatively.

  5. Adherence

    Time frame: day 1, 2, 3 and 4 postoperatively.

    Adherence to study medication on day 1, 2, 3 and 4 postoperatively. Definition compliance: Full compliance: analgesia used as prescribed "yes", no compliance: analgesia used as prescribed "no"

  6. Piritramide

    Time frame: after surgery until discharge of PACU (up to 3 hours after surgery)

    Total amount of intravenous piritramide received in the post-operative care unit (PACU)

  7. Rescue medication

    Time frame: day 1, 2, 3 and 4 postoperatively

    The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no)

  8. Satisfaction with study medication, surgery and hospital care and telephone follow-up

    Time frame: at day 7 and 3 months postoperative

    Satisfaction with study medication, surgery and hospital care and telephone follow-up measured at day 7 and 3 months postoperative measured by an 11-point Numeric Rating Scale (NRS) where 0: totally unsatisfied and 10: totally satisfied

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery: a Double-blind, Randomized, Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2019
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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