Pain, PostoperativePhase 3NCT03775018
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass
A Phase 3 study testing Transversus abdominis plane blockade and Intravenous analgesia in people with Pain, Postoperative, run by Hospital General Universitario Elche.
Trial summary
Patients will be randomized into 2 groups: TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia IV: Patients receiving only intravenous Acetaminophen analgesia Postoperative pain 24 hours after surgery will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Transversus abdominis plane blockade and Intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2018to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure
Who cannot join
- Patients undergoing OAGB as revisional procedure
- Patients undergoing other bariatric procedures
- Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
- Patients with history of allegy to local anesthetic drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
Patients will be randomized into 2 groups:
- TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
- IV: Patients receiving only intravenous Acetaminophen analgesia
Postoperative pain 24 hours after surgery will be evaluated.
Read the detailed description
Patients will be randomized into 2 groups:
- TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
- IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)
Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.
- Conditions
- Pain, Postoperative
- Being tested
- Transversus abdominis plane blockade, Intravenous analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockadeProcedure or surgery
Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.
Intravenous analgesiaDrug
Acetaminophen 1g/6h iv will be administered
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plain blockade | Experimental | The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia Receives: Procedure: Transversus abdominis plane blockade; Drug: Intravenous analgesia |
| Intravenous analgesia | Active comparator | The patients will receive intravenous analgesia with Acetaminophen (1g/6h) Receives: Drug: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start13 Dec 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 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
- Damian Garcia, MD, PhD, Study director, Hospital Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775018
- Sponsor's protocol ID
- HRJC 18-14
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 13 Dec 2018
- 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 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)
- ClinicalTrials.gov ID
- NCT03775018
- Acronym / sponsor ID
- HRJC 18-14
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 13 Dec 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 13 Dec 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.
Patients will be randomized into 2 groups:
- TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
- IV: Patients receiving only intravenous Acetaminophen analgesia
Postoperative pain 24 hours after surgery will be evaluated.
Detailed description
Patients will be randomized into 2 groups:
- TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
- IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)
Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plain blockade | Experimental | Procedure: Transversus abdominis plane blockade, Drug: Intravenous analgesiaThe patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia |
| Intravenous analgesia | Active comparator | Drug: Intravenous analgesiaThe patients will receive intravenous analgesia with Acetaminophen (1g/6h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure
Key exclusion criteria (4 listed)
- Patients undergoing OAGB as revisional procedure
- Patients undergoing other bariatric procedures
- Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
- Patients with history of allegy to local anesthetic drugs
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 |
|---|---|---|
| Transversus abdominis plane blockadePatients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels. | Procedure or surgery | Transversus abdominis plain blockade |
| Intravenous analgesiaAcetaminophen 1g/6h iv will be administered | Drug | Intravenous analgesia, Transversus abdominis plain blockade |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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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.
Damian Garcia, MD, PhD study director
Hospital Rey Juan Carlos
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transversus abdominis plane blockade and Intravenous analgesia in people with Pain, Postoperative, run by Hospital General Universitario Elche.
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 1 inclusion and 4 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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, MD, PhD ((0034)630534808, 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 13 Dec 2018.