Pain, PostoperativePhase 4NCT03007927
Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
A Phase 4 study testing Bupivacaine-Dexamethasone and Bupivacaine- physiological solution in people with Pain, Postoperative, run by SEBASTIAN ROCHE at 1 site in Argentina.
Trial summary
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine-Dexamethasone and Bupivacaine- physiological solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2016to 29 Jun 2017
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Unilateral inguinal hernioplasty.
- That the surgery is performed in the Ambulatory Surgery Unit (UCA).
Who cannot join
- Recurrent hernia.
- allergies, ongoing infections, diabetes.
- Background of rejection of prosthetic material (mesh).
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires, Peron 4190
Buenos Aires, Buenos Aires F.D., C1199ABB
About this study
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh
Read the detailed description
This study will be: controlled, prospective, randomized and double blind.
Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:
(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.
(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.
Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .
It will also evaluate analgesic consumption, complications and labor return
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine-Dexamethasone, Bupivacaine- physiological solution
- Keywords
- pain, hernia repair, Dexamethasone
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-DexamethasoneDrug
Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
Bupivacaine- physiological solutionDrug
Bupivacaine 1,5 mg/kg- physiological solution
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine-Dexamethasone | Experimental | bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml Receives: Drug: Bupivacaine-Dexamethasone |
| Bupivacaine- physiological solution | Active comparator | bupivacaine 1,5 mg/kg + physiological solution Receives: Drug: Bupivacaine- physiological solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain postoperative
It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
Measured: 3 month
Secondary outcomes (1)
take analgesic
Medication journal completed by patient
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEBASTIAN ROCHE
- Sponsor type
- University, hospital or other
- Collaborators
- Sebastián Roche, MD, Santiago Bertone, MD, Claudio Brandi, MD
- Responsible party
- Sponsor-investigator, SEBASTIAN ROCHE, Hospital Italiano de Buenos Aires
- Investigators
- Sebastian SR Roche, doctor, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007927
- Sponsor's protocol ID
- 2736
- Status last verified
- Aug 2017
- First submitted
- 20 Dec 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh
- ClinicalTrials.gov ID
- NCT03007927
- Acronym / sponsor ID
- 2736
- Conditions
- Pain, Postoperative
- Keywords
- pain, hernia repair, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SEBASTIAN ROCHEUniversity, hospital or other
- Collaborators
- Sebastián Roche, MD, Santiago Bertone, MD, Claudio Brandi, MD
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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.
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh
Detailed description
This study will be: controlled, prospective, randomized and double blind.
Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention:
(Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml.
(Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.
Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days .
It will also evaluate analgesic consumption, complications and labor return
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine-Dexamethasone | Experimental | Drug: Bupivacaine-Dexamethasonebupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml |
| Bupivacaine- physiological solution | Active comparator | Drug: Bupivacaine- physiological solutionbupivacaine 1,5 mg/kg + physiological solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years.
- Unilateral inguinal hernioplasty.
- That the surgery is performed in the Ambulatory Surgery Unit (UCA).
Key exclusion criteria (3 listed)
- Recurrent hernia.
- allergies, ongoing infections, diabetes.
- Background of rejection of prosthetic material (mesh).
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 |
|---|---|---|
| Bupivacaine-DexamethasoneBupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg | Drug | Bupivacaine-Dexamethasone |
| Bupivacaine- physiological solutionBupivacaine 1,5 mg/kg- physiological solution | Drug | Bupivacaine- physiological solution |
Primary outcome
pain postoperative
Time frame: 3 month
It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
1 secondary outcome
take analgesic
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
Sebastian SR Roche, doctor principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-Dexamethasone and Bupivacaine- physiological solution in people with Pain, Postoperative, run by SEBASTIAN ROCHE at 1 site in Argentina.
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 3 inclusion and 3 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 22 Feb 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain postoperative (time frame: 3 month). 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 22 Feb 2018.