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Completed

NCT Number: NCT05222789

Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

This observational prospective study aims to evaluate the postoperative analgesic effect of a regional anesthesia thechnique (TAP block) in patients undergoing scheduled laparoscopic intestinal resection for intestinal cancer. ASA I-III patients operated between May 1 and September 30, 2019 under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain, Chronic Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

About this study

The transverse abdominal plane (TAP) block is a regional anesthesia technique that blocks the afferent nerves of the anterolateral abdominal wall. This observational prospective study aims to evaluate the postoperative analgesic effect in patients undergoing laparoscopic intestinal resection. ASA I-III patients operated on a scheduled basis, between May 1 and September 30, 2019, by laparoscopy for intestinal cancer resection under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I-III
  • Operated on a scheduled basis for laparoscopic intestinal cancer resection

Exclusion criteria

  • Under 18 years old
  • Language barrier
  • Cognitive impairment or inability to collaborate in clinical assessment during the study
  • Drug or alcohol abuse
  • Habitual intake of opioids
  • Consumption of analgesics 24 hours before surgery
  • BMI <18 or >35 kg/m2

Treatment and study plan

TAP

Procedure

The transverse abdominal plane (TAP) block is a regional anesthesia technique performed using ultrasound that blocks the afferent nerves of the anterolateral abdominal wall, injecting local anesthetic in the fascial plane between the deep oblique and the transversus abdominis muscles.

Primary outcomes

  1. Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10

    Time frame: from the arrival to the postanesthesia care unit to the 4 postoperative hours

    assessed using visual analogue scale

  2. Intraoperative analgesic consumption

    Time frame: from the anesthesia induction to the end of the surgery

    assessed measuring the perioperative analgesics provided during the intraoperative period following routine clinical practice

Secondary outcomes

  1. Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10

    Time frame: 2 years postoperatively

    assessed using visual analogue scale

  2. Side effects

    Time frame: from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively)

    to record the perioperative side effects secondary to the analgesia administered perioperatively

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Registry information

Official study title

Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

Acronym: TAP

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2022
Registry last updated
Oct 16, 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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