A Study to Compare Two Techniques for Pain Control After Bariatric Surgery
NCT ID: NCT04427059
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
115 participants
INTERVENTIONAL
2020-06-15
2021-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A - laparoscopic assisted TAP block
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).
Transversus Abdominis Plane (TAP) block
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.
Arm B - 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).
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.
Interventions
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Transversus Abdominis Plane (TAP) block
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)
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.
Eligibility Criteria
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Inclusion Criteria
* age ≥ 18 years
* signed informed consent
Exclusion Criteria
* known allergy to local anesthetics
* Chronic pain syndrome.
18 Years
ALL
No
Sponsors
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Fabio Garofalo
OTHER
Responsible Party
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Fabio Garofalo
Principal Investigator
Principal Investigators
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Fabio Garofalo, MD
Role: PRINCIPAL_INVESTIGATOR
EOC Surgeery Department
Locations
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Ospedale Regionale di Lugano, Civico e Italiano
Lugano, , Switzerland
Countries
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Other Identifiers
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ORL-CHIR-008
Identifier Type: -
Identifier Source: org_study_id
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