Pain, PostoperativePhase 3NCT03203070
Laparoscopic-guided TAP Block in Patients Undergoing Gastric Bypass
A Phase 3 study testing Metamizol iv and TAP block in people with Pain, Postoperative, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Metamizol iv and TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to Sep 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 and obesity associated comorbidities
- Patients undergoing laparoscopic Roux en Y gastric bypass
Who cannot join
- Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass
- Patients undergoing open bariatric surgery
Trial locations and contacts
1 site in 1 country.
Manuel Duran contact
Spain1 site, 1 recruiting
- Recruiting
General Hospital Elche
Elche, Alicante, 03203
Jaime Ruiz-Tovar, (0034)630534808, jruiztovar@gmail.com
About this study
Official title: Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
A prospective randomized trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.
Read the detailed description
A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.
- Conditions
- Pain, Postoperative
- Being tested
- Metamizol iv, TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metamizol ivDrug
Also called Nolotil
Postoperative analgesia iv with Metamizol 2g/8h will be administered.
TAP blockProcedure or surgery
Also called Transversus abdominis plane block
Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| Metamizol iv | Active comparator | The patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain. Receives: Drug: Metamizol iv |
| TAP block | Experimental | The patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain. Receives: Drug: Metamizol iv; Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain quantification will be assessed with a Visual Analogic Scale
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 posted29 Jun 2017
- Study start1 Mar 2017
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 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
- Manule Duran, Study director, Hospital Universitario Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203070
- Sponsor's protocol ID
- HRJC/2017/17
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8.
PubMed 29980989
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic-guided Transversus Abdominis Plane (TAP) Block for Postoperative Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03203070
- Acronym / sponsor ID
- HRJC/2017/17
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 29 Jun 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 trial will be performed. Patients undergoing gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided transversus abdominis plane (TAP) block as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia, and patients receiving only postoperative intravenous analgesia (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24h after surgery and morphine needs will be quantified.
Detailed description
A prospective randomized trial will be performed. Patients undergoing laparoscopic Roux-en-Y gastric bypass will be randomized into 2 groups: patients undergoing laparoscopic-guided TAP block with 30 ml Bupivacaine 0.5%, as part of multimodal analgesia (Group 1), associated with postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h), and patients receiving only postoperative intravenous analgesia (Metamizol 2g/8h and Acetaminophen 1g/8h) (Group 2).
Postoperative pain will be assessed with a Visual Analogic Scale 24 hours after surgery and morphine needs will be quantified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metamizol iv | Active comparator | Drug: Metamizol ivThe patients will receive only intravenous analgesia with Metamizole 2g/8 hours for control of postoperative pain. |
| TAP block | Experimental | Drug: Metamizol iv, Procedure: TAP blockThe patients will receive intravenous analgesia with Metamizol iv 2g/8h and intraoperative laparoscopic-guided TAP block for control of postoperative pain. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) >40 Kg/m2
- BMI >35 Kg/m2 and obesity associated comorbidities
- Patients undergoing laparoscopic Roux en Y gastric bypass
Key exclusion criteria (2 listed)
- Patients undergoing other bariatric procedures, different than Roux en Y gastric bypass
- Patients undergoing open bariatric 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 |
|---|---|---|
| Metamizol ivAlso: NolotilPostoperative analgesia iv with Metamizol 2g/8h will be administered. | Drug | Metamizol iv, TAP block |
| TAP blockAlso: Transversus abdominis plane blockIntraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5% | Procedure or surgery | TAP block |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
Pain quantification will be assessed with a Visual Analogic Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 29980989Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8.
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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 contact
Manule Duran study director
Hospital Universitario 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 Metamizol iv and TAP block in people with Pain, Postoperative, 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 3 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 29 Jun 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 (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?
On the ClinicalTrials.gov record for NCT03203070, 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 29 Jun 2017.