Pain, PostoperativeNCT04427059
A Study to Compare Two Techniques for Pain Control After Bariatric Surgery
A study testing Transversus Abdominis Plane (TAP) block and Port-Site Infiltration (PSI) in people with Pain, Postoperative and Bariatric Surgery Candidate, run by Fabio Garofalo at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Bariatric Surgery Candidate
- What is being tested?
- Transversus Abdominis Plane (TAP) block and Port-Site Infiltration (PSI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2020to 7 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective bariatric surgery
- age ≥ 18 years
- signed informed consent
Who cannot join
- Pregnant or lactating women,
- known allergy to local anesthetics
- Chronic pain syndrome.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano, Civico e Italiano
Lugano, 6900
About this study
Official title: Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)
The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.
- Conditions
- Pain, Postoperative, Bariatric Surgery Candidate
- Being tested
- Transversus Abdominis Plane (TAP) block, Port-Site Infiltration (PSI)
- Keywords
- Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations
- Medical subject headings
- Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane (TAP) blockProcedure or surgery
The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum.
A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle.
The procedure is then repeated identically on the contralateral side.
Port-Site Infiltration (PSI)Procedure or surgery
The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - laparoscopic assisted TAP block | Experimental | Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA). Receives: Procedure: Transversus Abdominis Plane (TAP) block |
| Arm B - PSI | Active comparator | Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI). Receives: Procedure: Port-Site Infiltration (PSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
Measured: at 24 hours post surgery
Secondary outcomes (5)
postoperative pain
Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 18 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
Measured: at 3, 6, 12, 18 hours from surgery
Number of Participants With Ropivacaine-Related Adverse Events
Measured: from surgery up to six weeks after surgery
Number of participants with complications
Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,
Measured: from surgery up to six weeks after surgery
lenght of hospital stay
number of days the participant is being hospitalized
Measured: during hospitalization,approximately 4 days
in hospital satisfaction
In hospital satisfaction (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction.
This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)
Measured: during hospitalization,approximately 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jun 2020
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Garofalo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Garofalo, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Fabio Garofalo, MD, Principal investigator, EOC Surgeery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427059
- Sponsor's protocol ID
- ORL-CHIR-008
- Status last verified
- Oct 2021
- First submitted
- 1 Jun 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)
- ClinicalTrials.gov ID
- NCT04427059
- Acronym / sponsor ID
- ORL-CHIR-008
- Conditions
- Pain, Postoperative, Bariatric Surgery Candidate
- Keywords
- Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Fabio GarofaloUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 11 Jun 2020 (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 purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - laparoscopic assisted TAP block | Experimental | Procedure: Transversus Abdominis Plane (TAP) blockPatients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA). |
| Arm B - PSI | Active comparator | Procedure: Port-Site Infiltration (PSI)Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective bariatric surgery
- age ≥ 18 years
- signed informed consent
Key exclusion criteria (3 listed)
- Pregnant or lactating women,
- known allergy to local anesthetics
- Chronic pain syndrome.
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 (TAP) blockThe laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum. A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle. The procedure is then repeated identically on the contralateral side. | Procedure or surgery | Arm A - laparoscopic assisted TAP block |
| Port-Site Infiltration (PSI)The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered. | Procedure or surgery | Arm B - PSI |
Primary outcome
Postoperative Pain
Time frame: at 24 hours post surgery
Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
5 secondary outcomes
postoperative pain
Time frame: at 3, 6, 12, 18 hours from surgery
Number of Participants With Ropivacaine-Related Adverse Events
Time frame: from surgery up to six weeks after surgery
Number of participants with complications
Time frame: from surgery up to six weeks after surgery
lenght of hospital stay
Time frame: during hospitalization,approximately 4 days
in hospital satisfaction
Time frame: during hospitalization,approximately 4 days
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 6 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Fabio Garofalo, MD principal investigator
EOC Surgeery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane (TAP) block and Port-Site Infiltration (PSI) in people with Pain, Postoperative and Bariatric Surgery Candidate, run by Fabio Garofalo at 1 site in Switzerland.
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 6 Oct 2021. 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 Switzerland. 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?
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?
Postoperative Pain (time frame: at 24 hours post 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 6 Oct 2021.