Trial · NCT01345162
Assessment and Prevention of Acute Post-herniotomy Pain
NCT01345162, Phase 4, Completed, Fondazione IRCCS Policlinico San Matteo di Pavia; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment and Prevention of Acute Post-herniotomy Pain. Trials, record NCT01345162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01345162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment and Prevention of Acute Post-herniotomy Pain
- NCT number
- NCT01345162
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 200 participants, actual
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Conditions
- Hernia
- Interventions
- Ketorolac postoperative, postoperative Patrol, intraoperative analgesia, intraoperative analgesia
- First posted
- 2011-04-29
- Last updated
- 2014-06-09
- Results first posted
- 2014-06-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analgesic Efficacy | 4 days postherniotomy | 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. |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 4 days postherniotoy | All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups. |
| Secondary | Difference in Recovering Daily Activity | 4 days after surgical procedure | Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement) |
| Secondary | Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications | 4 days postherniotomy | 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. |
| Secondary | Development of Persistent Postoperative Pain | Up to 3 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Analgesic Efficacy | 4 days postherniotomy | percentage of patients with NRS≥4 | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 4 days postherniotoy | |||
| SECONDARY | Difference in Recovering Daily Activity | 4 days after surgical procedure | |||
| SECONDARY | Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications | 4 days postherniotomy | |||
| SECONDARY | Development of Persistent Postoperative Pain | Up to 3 months |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Analgesic Efficacy | Ketorolac | 26.5 | percentage of patients with NRS≥4 | ||
| Analgesic Efficacy | Acetaminophene + Tramadol | 32.3 | percentage of patients with NRS≥4 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketorolac | 100 | |
| Overall Study | STARTED | Acetaminophene + Tramadol | 100 | |
| Overall Study | COMPLETED | Ketorolac | 98 | |
| Overall Study | COMPLETED | Acetaminophene + Tramadol | 96 | |
| Overall Study | NOT COMPLETED | Ketorolac | 2 | |
| Overall Study | NOT COMPLETED | Acetaminophene + Tramadol | 4 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | stipsis | Gastrointestinal disorders | Ketorolac | 5 | 98 | 5 |
| other | stipsis | Gastrointestinal disorders | Acetaminophene + Tramadol | 9 | 96 | 9 |
| other | bleeding | Blood and lymphatic system disorders | Ketorolac | 1 | 98 | 1 |
| other | bleeding | Blood and lymphatic system disorders | Acetaminophene + Tramadol | 0 | 96 | 0 |
| other | vertigo headache parestesia | Nervous system disorders | Ketorolac | 2 | 98 | 2 |
| other | vertigo headache parestesia | Nervous system disorders | Acetaminophene + Tramadol | 5 | 96 | 5 |
| other | hypotension | Cardiac disorders | Ketorolac | 1 | 98 | 1 |
| other | hypotension | Cardiac disorders | Acetaminophene + Tramadol | 0 | 96 | 0 |
| other | reactive hydrocele | Renal and urinary disorders | Ketorolac | 1 | 98 | 1 |
| other | reactive hydrocele | Renal and urinary disorders | Acetaminophene + Tramadol | 1 | 96 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketorolac | ||
| Total, all-cause mortality | Acetaminophene + Tramadol | ||
| Total, other adverse events | Ketorolac | 6 | 98 |
| Total, other adverse events | Acetaminophene + Tramadol | 12 | 96 |
| Total, serious adverse events | Ketorolac | 0 | 98 |
| Total, serious adverse events | Acetaminophene + Tramadol | 0 | 96 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26329661 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ketorolac vs Acetaminophene + Tramadol: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01345162
GET https://conductscience.org/api/trials/v1/NCT01345162/registered