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| Name | Class |
|---|---|
| University of Pavia | OTHER |
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The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.
Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even brief intervals of acute pain can induce long-term neuronal remodeling and sensitization, chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with subsequence damage to nerve structures. The aim of our study is to analyze analgesic efficacy, safety and prevention of persistent postsurgical pain of two different pharmacological strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketorolac | Other | Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then Ketorolac postoperative 10mg 1cp x 3/die, from the day of surgery for 4 days after surgery. |
|
| acetaminophene+tramadol | Other | Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then postoperative Patrol (acetaminophene 325mg+tramadol 37,5mg) 1cp x 3/die for 4 days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac postoperative | Drug | Ketorolac 10mg 1cp x 3/die |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Efficacy | percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible). NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs. | 4 days postherniotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups. | 4 days postherniotoy |
| Difference in Recovering Daily Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Cavalloro, MD | IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Pavia | Lomabardy | 27100 | Italy | ||
| Ospedale di Circolo e Fondazione Macchi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26329661 | Derived | Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | Ketorolac 10mg 1cp x 3/die postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die |
| FG001 | Acetaminophene + Tramadol | acetaminophene 325mg+tramadol 37,5mg 1cp x 3/die postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
patients enrolled who completed the evaluations
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | Ketorolac 10mg 1cp x 3/die postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die |
| BG001 | Acetaminophene + Tramadol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analgesic Efficacy | percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible). NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs. | Posted | Number | percentage of patients with NRS≥4 | 4 days postherniotomy |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac | Ketorolac 10mg 1cp x 3/die postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stipsis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Massimo Allegri | IRCCS Policlinico S Matteo | 00390382502627 | massimo.allegri@unipv.it |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D020910 | Ketorolac |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| postoperative Patrol | Drug | acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die |
|
|
| intraoperative analgesia | Drug | ketorolac 30 mg iv |
|
|
| intraoperative analgesia | Drug | Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg |
|
|
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement) |
| 4 days after surgical procedure |
| Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications | Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain. Assessment of any difference between the two groups. | 4 days postherniotomy |
| Development of Persistent Postoperative Pain | Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain. | Up to 3 months |
| Varese |
| Lombardy |
| 21100 |
| Italy |
acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups. | Not Posted | 4 days postherniotoy |
| Secondary | Difference in Recovering Daily Activity | Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement) | Not Posted | 4 days after surgical procedure |
| Secondary | Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications | Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain. Assessment of any difference between the two groups. | Not Posted | 4 days postherniotomy |
| Secondary | Development of Persistent Postoperative Pain | Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain. | Not Posted | Up to 3 months |
| 0 |
| 98 |
| 6 |
| 98 |
| EG001 | Acetaminophene + Tramadol | acetaminophene 325mg+tramadol 37,5mg 1cp x 3/die postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die | 0 | 96 | 12 | 96 |
| bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| vertigo headache parestesia | Nervous system disorders | Non-systematic Assessment |
|
| hypotension | Cardiac disorders | Non-systematic Assessment |
|
| reactive hydrocele | Renal and urinary disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |