AnalgesiaNCT04082728
Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery
A study testing Metamizole in people with Analgesia and Surgery, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Metamizole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Nov 2019to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Metamizole, Placebo oral tablet
- Keywords
- ambulant surgery, post-operative medication, recovery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizoleDrug
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 tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after the surgery
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: day 1, 2, 3 and 4 postoperatively.
Piritramide
Total amount of intravenous piritramide received in the post-operative care unit (PACU)
Measured: 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)
Measured: 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
Measured: at day 7 and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start28 Nov 2019
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is designed as a mono-center, prospective, double-blind, randomized placebo controlled superiority trial comparing 2 groups of patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082728
- Sponsor's protocol ID
- Metamizole002
- Status last verified
- Feb 2022
- First submitted
- 2 Sep 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36632758
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Added Value of Metamizole to Standard Post-operative Treatment After Ambulant Surgery: a Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04082728
- Acronym / sponsor ID
- Metamizole002
- Keywords
- ambulant surgery, post-operative medication, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is designed as a mono-center, prospective, double-blind, randomized placebo controlled superiority trial comparing 2 groups of patients
| Arm | Type | Receives |
|---|---|---|
| Metamizole | Active comparator | Drug: MetamizolePatients 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. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetamizolePatients 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. | Drug | Metamizole |
| Placebo oral tabletPatients 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. | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
Quality of recovery
Time frame: at baseline and days 7, 14, 28 and 3 months postoperatively.
Quality of recovery
Time frame: at baseline and days 7, 14, 28 and 3 months postoperatively.
Postoperative pain
Time frame: at baseline, at discharge and at day 1, 2, 3, 4, 7, 14, 28 and at 3 months after surgery
Simple Shoulder test
Time frame: at baseline and days 7, 14, 28 and 3 months postoperatively.
Adherence
Time frame: day 1, 2, 3 and 4 postoperatively.
Piritramide
Time frame: after surgery until discharge of PACU (up to 3 hours after surgery)
Rescue medication
Time frame: day 1, 2, 3 and 4 postoperatively
Satisfaction with study medication, surgery and hospital care and telephone follow-up
Time frame: at day 7 and 3 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 36632758Stessel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metamizole in people with Analgesia and Surgery, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain on day 1 (time frame: 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.