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Clinical Trials/NCT05222789
NCT05222789
Completed
N/A

Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

Dr. Negrin University Hospital1 site in 1 country105 target enrollmentMay 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain, Acute
Sponsor
Dr. Negrin University Hospital
Enrollment
105
Locations
1
Primary Endpoint
Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
March 20, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Dr. Negrin University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ángel Becerra

Principal Investigator

Dr. Negrin University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

  • Side effects(from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively))
  • Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10(2 years postoperatively)

Study Sites (1)

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