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Completed

NCT Number: NCT06383234

REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

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).

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Key information

Conditions

Pain Acute Pain Agnosia Analgesia Anesthesia Bariatric Surgery Candidate Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Campus Bio-medico

Rome, 00128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LG-TAP block with local anesthetic

Procedure

The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Ropivacaine 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.

LG-TAP block with saline solution

Procedure

The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.

Port site infiltration

Procedure

Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon

Primary outcomes

  1. Pain Score

    Time frame: 24 hours

    A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery

Secondary outcomes

  1. Morphine Consumption

    Time frame: 24 hours

    Total of intravenous morphine (expressed in milligrams) administered administered during the first 24 hours after surgery

  2. Toradol Consumption

    Time frame: 24 hours

    Total of intravenous toradol (expressed in milligrams) administered administered during the first 24 hours after surgery

  3. Nausea and/or vomiting

    Time frame: 48 hours

    Incidence of nausea and/or vomiting

  4. Lenght of Hospital Stay

    Time frame: 72 hours

    Time between surgery and dismission from the hospital

  5. Time to walking

    Time frame: 72 hours

    Time between surgery and patient starting to walk

  6. Time to first flatus

    Time frame: 72 hours

    Time between surgery and patient having flatus

  7. Surgical Complication

    Time frame: 7 days

    Incidence of complications related to surgery

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Acronym: REPABS-SG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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