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Completed

NCT Number: NCT04427059

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

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.

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Key information

Conditions

Pain, Postoperative Bariatric Surgery Candidate Bites and Stings Chemically-Induced Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Lugano, Civico e Italiano

Lugano, 6900, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Transversus abdominis plane (TAP) block

Procedure

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)

Procedure

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.

Primary outcomes

  1. Postoperative Pain

    Time frame: at 24 hours post surgery

    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.

Secondary outcomes

  1. postoperative pain

    Time frame: at 3, 6, 12, 18 hours from surgery

    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.

  2. Number of Participants With Ropivacaine-Related Adverse Events

    Time frame: from surgery up to six weeks after surgery

  3. Number of participants with complications

    Time frame: from surgery up to six weeks after surgery

    Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,

  4. lenght of hospital stay

    Time frame: during hospitalization,approximately 4 days

    number of days the participant is being hospitalized

  5. in hospital satisfaction

    Time frame: during hospitalization,approximately 4 days

    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)

Sponsors and collaborators

Lead sponsor

Fabio Garofalo

Other

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Oct 6, 2021

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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