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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Surgery; Recovery
• Intervention / Treatment: Drug: Metamizole; Drug: Placebo oral tablet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Metamizole; 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; 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_COMPARATOR: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery	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.	at baseline and days 7, 14, 28 and 3 months postoperatively.
Quality of recovery	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.	at baseline and days 7, 14, 28 and 3 months postoperatively.
Postoperative pain	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.	at baseline, at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months after surgery
Simple Shoulder test	Simple shoulder test (SST) measured at baseline and days 7, 14, 28 and 3 months postoperatively.	at baseline and days 7, 14, 28 and 3 months postoperatively.
Adherence	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"	day 1, 2, 3 and 4 postoperatively.
Piritramide	Total amount of intravenous piritramide received in the post-operative care unit (PACU)	after surgery until discharge of PACU (up to 3 hours after surgery)
Rescue medication	The use of rescue medication (Tramadol) at home on day 1, 2, 3 and 4 postoperatively (yes/no)	day 1, 2, 3 and 4 postoperatively
Satisfaction with study medication, surgery and hospital care and telephone follow-up	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	at day 7 and 3 months postoperative

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2019
• Primary Completion (ACTUAL): February 7, 2022
• Study Completion (ACTUAL): February 7, 2022

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: recovery; ambulant surgery; post-operative medication
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Dipyrone
• Other Study ID Numbers: Metamizole002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No