Postoperative PainPERiXNCT03685370
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique
A study testing LOS and X-ray placement in people with Postoperative Pain and Postoperative Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Postoperative Complications, Pancreatic Cancer
- What is being tested?
- LOS and X-ray placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 30 Sep 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for open pancreatic surgery
- ASA < = 3
Who cannot join
- scoliosis
- coagulation abnormalities
- antiplatelet drugs (except ASA)
- history of back surgery
- anticipated need of ICU stay
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliero-universitaria integrata Verona
Verona, Veneto, 37126
Alvise Martini, MD, 0458124666, alvise.martini@univr.it
About this study
Official title: PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery
The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.
Read the detailed description
About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.
Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.
- Conditions
- Postoperative Pain, Postoperative Complications, Pancreatic Cancer, Haemodynamic Instability
- Being tested
- LOS, X-ray placement
- Keywords
- Epidural catheter, postoperative pain, LOS
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOSProcedure or surgery
placement of epidural catheters with LOS technique
X-ray placementProcedure or surgery
placement of epidural catheters with x-ray guide
| Study group | Role | What they receive |
|---|---|---|
| LOS group | Active comparator | Patients randomized to recieve epidural catheter placement with LOS technique, without any Rx control Receives: Procedure: LOS |
| X-ray group | Experimental | Patients randomized for X-ray placement of epidural catheter Receives: Procedure: X-ray placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheters malfunctions in LOS and X-ray group
malfunctional catheters are defined as following:
- symptomatic hypotension due to epidural infusion
- NRS > 6 in the first postoperative day and NRS > 4 in subsequent postoperative day
- overt malpositioning:
- rx evidence of catheter's tip under T10 during routine rx or TC
- NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and response to lidocaine 1% 6ml bolus (low tip)
- NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and NO response to lidocaine 1% 6ml bolus ( not in epidural space or very low tip)
- evidence of catheter accidental removal
Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.
Measured: every day until 7th postoperative day
Secondary outcomes (2)
Evaluate daily pain differences between groups: NRS (Numeric rating scale)
Parameter used
-higher postoperative daily numeric rating scale (NRS) until catheter removal
Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.
Measured: every day until 7th postoperative day
Monitoring postoperative surgical complications between groups
Complications are considered as:
- bleedings
- infections
- pancreatic fistulas (degree)
- biliary fistulas
- abdominal collections
- ICU admission
- needs of new surgery (for any reasons)
- pneumonia
- delayed gastric emptying
Measured: at 30th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Mar 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvise Martini, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Alvise Martini, MD, Principal investigator, AOUI Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685370
- Sponsor's protocol ID
- PERiX
- Acronym
- PERiX
- Status last verified
- Sep 2018
- First submitted
- 27 Jun 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique: Outcome Influence on Patient Underwent Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03685370
- Acronym / sponsor ID
- PERiX / PERiX
- Conditions
- Postoperative Pain, Postoperative Complications, Pancreatic Cancer, Haemodynamic Instability
- Keywords
- Epidural catheter, postoperative pain, LOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 26 Sep 2018 (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 use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.
Detailed description
About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.
Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOS group | Active comparator | Procedure: LOSPatients randomized to recieve epidural catheter placement with LOS technique, without any Rx control |
| X-ray group | Experimental | Procedure: X-ray placementPatients randomized for X-ray placement of epidural catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for open pancreatic surgery
- ASA < = 3
Key exclusion criteria (5 listed)
- scoliosis
- coagulation abnormalities
- antiplatelet drugs (except ASA)
- history of back surgery
- anticipated need of ICU stay
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 |
|---|---|---|
| LOSplacement of epidural catheters with LOS technique | Procedure or surgery | LOS group |
| X-ray placementplacement of epidural catheters with x-ray guide | Procedure or surgery | X-ray group |
Primary outcome
Incidence of catheters malfunctions in LOS and X-ray group
Time frame: every day until 7th postoperative day
malfunctional catheters are defined as following: * symptomatic hypotension due to epidural infusion * NRS > 6 in the first postoperative day and NRS > 4 in subsequent postoperative day * overt malpositioning: * rx evidence of catheter's tip under T10 during routine rx or TC * NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and response to lidocaine 1% 6ml bolus (low tip) * NRS > 6 (due to pain at T7-10 dermatomers) with 5 cc/h catheter infusion and NO response to lidocaine 1% 6ml bolus ( not in epidural space or very low tip) * evidence of catheter accidental removal Numerical Rating Scale (NRS) is used to assess pain. Patients self-report actual pain on 0 to 10 scale where 0 is no pain and 10 is the worst immaginable pain.
2 secondary outcomes
Evaluate daily pain differences between groups: NRS (Numeric rating scale)
Time frame: every day until 7th postoperative day
Monitoring postoperative surgical complications between groups
Time frame: at 30th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Alvise Martini, MD principal investigator
AOUI Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOS and X-ray placement in people with Postoperative Pain and Postoperative Complications, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2018. 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvise Martini, MD (0458124666, alvise.martini@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheters malfunctions in LOS and X-ray group (time frame: every day until 7th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2018.