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PainREPABS-SGNCT06383234

REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

A study testing LG-TAP block with local anesthetic, LG-TAP block with saline solution and Port site infiltration in people with Pain and Postoperative Pain, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative Pain, Acute Pain
What is being tested?
LG-TAP block with local anesthetic, LG-TAP block with saline solution and Port site infiltration
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteItaly
Study dates
10 Jan 2022to 28 Sep 2023
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

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Policlinico Universitario Campus Bio-medico

    Rome, 00128

Other trials in Italy

About this study

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).

Being tested
LG-TAP block with local anesthetic, LG-TAP block with saline solution, Port site infiltration
Medical subject headings
Pain, Pain, Postoperative, Acute Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LG-TAP block with local anestheticProcedure or surgery

    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 solutionProcedure or surgery

    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 infiltrationProcedure or surgery

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

Study groups in NCT06383234
Study groupRoleWhat they receive
LG-TAPExperimentalThe laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Ropivacaine Hydrochloride 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.
Receives: Procedure: LG-TAP block with local anesthetic; Procedure: Port site infiltration
SALINEPlacebo comparatorThe laparoscopic guided TAP Block was performed 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.
Receives: Procedure: LG-TAP block with saline solution; Procedure: Port site infiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Score

    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

    Measured: 24 hours

Secondary outcomes (7)

  1. Morphine Consumption

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

    Measured: 24 hours

  2. Toradol Consumption

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

    Measured: 24 hours

  3. Nausea and/or vomiting

    Incidence of nausea and/or vomiting

    Measured: 48 hours

  4. Lenght of Hospital Stay

    Time between surgery and dismission from the hospital

    Measured: 72 hours

  5. Time to walking

    Time between surgery and patient starting to walk

    Measured: 72 hours

  6. Time to first flatus

    Time between surgery and patient having flatus

    Measured: 72 hours

  7. Surgical Complication

    Incidence of complications related to surgery

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start10 Jan 2022
  3. Primary completion21 Sep 2023
  4. Study completion28 Sep 2023

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383234
Sponsor's protocol ID
PAR 89/21
Acronym
REPABS-SG
Status last verified
Apr 2024
First submitted
21 Apr 2024
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37740830

  • 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.

    PubMed 35143011

Questions about this trial

What is this clinical trial studying?

A study testing LG-TAP block with local anesthetic, LG-TAP block with saline solution and Port site infiltration in people with Pain and Postoperative Pain, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.

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 4 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 25 Apr 2024. 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 Italy. 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. Some participants in this study may receive a placebo. 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?

Pain Score (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383234, which also lists 2 linked publications.

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 25 Apr 2024.

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