Postoperative PainPhase 3NCT03212573
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
A Phase 3 study testing ERAS protocol in people with Postoperative Pain, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol. Postoperative pain 24 hours after surgery and hospital stay will be assessed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ERAS protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2016to Dec 2017
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) >40 Kg/m2
- BMI >35 Kg/m2 with obesity-associated comorbidities
Who cannot join
- Patients undergoing other bariatric procedures
- Patients undergoing bariatric revisional surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
General Hospital Elche
Elche, Alicante, 03203
Jaime Ruiz-Tovar, (0034)630534808, jruiztovar@gmail.com
About this study
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol.
Postoperative pain 24 hours after surgery and hospital stay will be assessed.
Read the detailed description
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia).
Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.
- Conditions
- Postoperative Pain
- Being tested
- ERAS protocol, Standard care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolCombination product
ERAS protocol includes early oral intake and deambulation and multimodal analgesia
Standard careCombination product
Oral intake and deambulation 24h after surgery and only intravenous analgesia.
| Study group | Role | What they receive |
|---|---|---|
| ERAS protocol | Experimental | ERAS protocol includes early oral intake (6 hours after surgery), early deambulation (6h after surgery) and multimodal analgesia (port-sites infiltration with Bupivacain 0.5% combined with postoperative intravenous analgesia) Receives: Combination Product: ERAS protocol |
| Standard care | Active comparator | Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs Receives: Combination Product: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Evaluated by Visual Analogic Scale
Measured: 24 hours after surgery
Secondary outcomes (1)
Hospital stay
Days
Measured: Days until patients´discharge: 2 days or more than 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Mar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Manuel Duran, Study chair, Hospital Rey Juan carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212573
- Sponsor's protocol ID
- HRJC17/18
- Status last verified
- Jul 2017
- First submitted
- 29 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03212573
- Acronym / sponsor ID
- HRJC17/18
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Jul 2017 (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.
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol.
Postoperative pain 24 hours after surgery and hospital stay will be assessed.
Detailed description
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia).
Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS protocol | Experimental | Combination Product: ERAS protocolERAS protocol includes early oral intake (6 hours after surgery), early deambulation (6h after surgery) and multimodal analgesia (port-sites infiltration with Bupivacain 0.5% combined with postoperative intravenous analgesia) |
| Standard care | Active comparator | Combination Product: Standard careOral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) >40 Kg/m2
- BMI >35 Kg/m2 with obesity-associated comorbidities
Key exclusion criteria (2 listed)
- Patients undergoing other bariatric procedures
- Patients undergoing bariatric revisional surgery
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 |
|---|---|---|
| ERAS protocolERAS protocol includes early oral intake and deambulation and multimodal analgesia | Combination product | ERAS protocol |
| Standard careOral intake and deambulation 24h after surgery and only intravenous analgesia. | Combination product | Standard care |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
Evaluated by Visual Analogic Scale
1 secondary outcome
Hospital stay
Time frame: Days until patients´discharge: 2 days or more than 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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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.
Manuel Duran study chair
Hospital Rey Juan carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ERAS protocol in people with Postoperative Pain, run by Hospital General Universitario Elche at 1 site in Spain.
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 2 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 11 Jul 2017. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jaime Ruiz-Tovar (0034630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24 hours after surgery). 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 11 Jul 2017.