A Phase 4 interventional study of Ketorolac postoperative and postoperative Patrol in Hernia, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 2 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Phase 4, Interventional, and Treatment
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.
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Ketorolac postoperative · Drug: intraoperative analgesia
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.
Drug: postoperative Patrol · Drug: intraoperative analgesia
Ketorolac 10mg 1cp x 3/die
Also known as: Toradol
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
Also known as: Patrol
ketorolac 30 mg iv
Also known as: Ketorolac
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Also known as: Tramadol
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.
Time frame: 4 days postherniotomy
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.
Time frame: 4 days postherniotoy
Difference in Recovering Daily Activity
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months
| Milestone | Ketorolac | Acetaminophene + Tramadol |
|---|---|---|
| Started | 100 | 100 |
| Completed | 98 | 96 |
| Not completed | 2 | 4 |
| Withdrew: Protocol violation | 2 | 4 |
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.
| percentage of patients with NRS≥4 | Ketorolac | Acetaminophene + Tramadol |
|---|---|---|
| Analgesic Efficacy | 26.5 | 32.3 |
All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups.
Results for this outcome have not been posted.
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketorolac | — | 0/98 (0%) | 6/98 (6.1%) |
| Acetaminophene + Tramadol | — | 0/96 (0%) | 12/96 (12.5%) |
| Event | Ketorolac | Acetaminophene + Tramadol |
|---|---|---|
| stipsisGastrointestinal disorders | 5/98 | 9/96 |
| vertigo headache parestesiaNervous system disorders | 2/98 | 5/96 |
| reactive hydroceleRenal and urinary disorders | 1/98 | 1/96 |
| bleedingBlood and lymphatic system disorders | 1/98 | 0/96 |
| hypotensionCardiac disorders | 1/98 | 0/96 |
| dyspneaRespiratory, thoracic and mediastinal disorders | 1/98 | 0/96 |
patients enrolled who completed the evaluations
| Age, Continuous(years) | Ketorolac | Acetaminophene + Tramadol | Total |
|---|---|---|---|
| Mean | 56.6 ± 14.6 | 56.6 ± 15 | 56.6 ± 14.8 |
| Sex: Female, Male(Participants) | Ketorolac | Acetaminophene + Tramadol | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 93 | 87 | 180 |
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Fondazione IRCCS Policlinico San Matteo di Pavia