Clinical trial NCT06383234: REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
Official title: REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Postoperative Pain
Acute Pain
Analgesia
Bariatric Surgery Candidate
Anesthesia
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).


Eligibility criteria: Inclusion Criteria:

* Elective Laparoscopic Sleeve Gastrectomy
* Body Mass Index (BMI) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
* BMI \> 40 kg/m², even in the absence of comorbidities
* ASA physical status score \< 4

Exclusion Criteria:

* ASA physical status score ≥ 4
* Patient's refusal or inability to sign the informed consent
* Allergies to any drug provided by the study protocol

Primary outcomes:
measure: Pain Score
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours
measure: Toradol Consumption
timeFrame: 24 hours
measure: Nausea and/or vomiting
timeFrame: 48 hours
measure: Lenght of Hospital Stay
timeFrame: 72 hours
measure: Time to walking
timeFrame: 72 hours
measure: Time to first flatus
timeFrame: 72 hours
measure: Surgical Complication
timeFrame: 7 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-medico
Study officials:
affiliation: Fondazione Policlinico Universitario Campus Bio-Medico
name: Vincenzo Bruni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mongelli F, Marengo M, Bertoni MV, Volonte F, Ledingham NS, Garofalo F. Laparoscopic-Assisted Transversus Abdominis Plane (TAP) Block Versus Port-Site Infiltration with Local Anesthetics in Bariatric Surgery: a Double-Blind Randomized Controlled Trial. Obes Surg. 2023 Nov;33(11):3383-3390. doi: 10.1007/s11695-023-06825-7. Epub 2023 Sep 23.
citation: Ripolles-Melchor J, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.