HerniaPhase 4PTSM04APHPNCT01345162
Assessment and Prevention of Acute Post-herniotomy Pain
A Phase 4 study testing Ketorolac postoperative, postoperative Patrol and intraoperative analgesia in people with Hernia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia
- What is being tested?
- Ketorolac postoperative, postoperative Patrol and intraoperative analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2010to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females over 18 years, under 80 years, scheduled for elective herniotomy
- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
- Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))
- Signed informed consent
Who cannot join
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- NSADs allergy
- cognitive or mental alterations
- coagulopathy
- piastrinemia < 100.000/mm3
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Policlinico San Matteo
Pavia, Lomabardy, 27100
Ospedale di Circolo e Fondazione Macchi
Varese, Lombardy, 21100
About this study
Official title: Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain
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.
Read the detailed description
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.
- Conditions
- Hernia
- Being tested
- Ketorolac postoperative, postoperative Patrol, intraoperative analgesia
- Keywords
- Herniotomy
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac postoperativeDrug
Also called Toradol
Ketorolac 10mg 1cp x 3/die
postoperative PatrolDrug
Also called Patrol
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
intraoperative analgesiaDrug
Also called Ketorolac
ketorolac 30 mg iv
intraoperative analgesiaDrug
Also called Tramadol
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketorolac postoperative; Drug: intraoperative analgesia |
| 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. Receives: Drug: postoperative Patrol; Drug: intraoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days postherniotomy
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Massimo Allegri, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Fabrizio Cavalloro, MD, Principal investigator, IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345162
- Sponsor's protocol ID
- 2009-011856-23
- Other IDs
- 2009
- Acronym
- PTSM04APHP
- Status last verified
- May 2014
- First submitted
- 19 Apr 2011
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26329661
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain
- ClinicalTrials.gov ID
- NCT01345162
- Acronym / sponsor ID
- PTSM04APHP / 2009-011856-23
- Conditions
- Hernia
- Keywords
- Herniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Posted 9 Jun 2014
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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketorolac | Other | Drug: Ketorolac postoperative, Drug: intraoperative analgesiaPatients 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 | Drug: postoperative Patrol, Drug: intraoperative analgesiaPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females over 18 years, under 80 years, scheduled for elective herniotomy
- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
- Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))
- Signed informed consent
Key exclusion criteria (8 listed)
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- NSADs allergy
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 |
|---|---|---|
| Ketorolac postoperativeAlso: ToradolKetorolac 10mg 1cp x 3/die | Drug | ketorolac |
| postoperative PatrolAlso: Patrolacetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die | Drug | acetaminophene+tramadol |
| intraoperative analgesiaAlso: Ketorolacketorolac 30 mg iv | Drug | acetaminophene+tramadol, ketorolac |
| intraoperative analgesiaAlso: TramadolTramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg | Drug | acetaminophene+tramadol, ketorolac |
Primary outcome
Analgesic Efficacy
Time frame: 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.
4 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 4 days postherniotoy
Difference in Recovering Daily Activity
Time frame: 4 days after surgical procedure
Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications
Time frame: 4 days postherniotomy
Development of Persistent Postoperative Pain
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26329661Bugada 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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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.
Fabrizio Cavalloro, MD principal investigator
IRCCS Policlinico San Matteo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac postoperative, postoperative Patrol and intraoperative analgesia in people with Hernia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
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 5 inclusion and 8 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analgesic Efficacy (time frame: 4 days postherniotomy). 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 NCT01345162, 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 9 Jun 2014.