A Study to Compare Two Techniques for Pain Control After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Pain, Postoperative, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Transversus Abdominis Plane (TAP) block
* Procedure: Port-Site Infiltration (PSI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective bariatric surgery age ≥ 18 years signed informed consent Exclusion Criteria: Pregnant or lactating women, known allergy to local anesthetics Chronic pain syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - laparoscopic assisted TAP block<br>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). | Procedure: Transversus Abdominis Plane (TAP) block<br>* 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.<br>|
| Active Comparator: Arm B - PSI<br>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). | Procedure: Port-Site Infiltration (PSI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3, 6, 12, 18 hours from surgery | 
| Number of Participants With Ropivacaine-Related Adverse Events |  | 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, | from surgery up to six weeks after surgery | 
| lenght of hospital stay | number of days the participant is being hospitalized | 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) | during hospitalization,approximately 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transversus Abdominis Plane (TAP) Block, Local Anesthetic Infiltrations