Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

NCT05222789 | Completed

• 1 other identifier: ARP-ANA-2015-01
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute; Postoperative Pain, Chronic

Outcome Measures

Primary Outcomes (2)

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

  assessed using visual analogue scale

  from the arrival to the postanesthesia care unit to the 4 postoperative hours

• Intraoperative analgesic consumption

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

  from the anesthesia induction to the end of the surgery

Secondary Outcomes (2)

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

  2 years postoperatively

• Side effects

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

Study Arms (2)

TAP block

Patients receiving TAP block preoperatively, following routine clinical practice

Procedure: TAP

Non-TAP

Patients not receiving TAP block preoperatively, following routine clinical practice

Interventions

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.

TAP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational prospective study comparing routine practice of analgesic management in consecutive surgical patients scheduled to undergo elective intestinal laparoscopic resection for suffering from intestinal cancer. 60 patients are expected to be included in this study and perioperative analgesic management prewarming will be performed following routine clinical practice. TAP block will be performed peroperatively under ultrasound control according to the anesthesiologist's decision. The patients will be followed up during the hospital stay (approximately one week) to evaluate the perioperative analgesic evolution and the appearance of secondary effects. A control will be carried out two years after surgery to evaluate the appearance of postoperative chronic pain.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Ángel Becerra

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

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Ángel Becerra

  Hospital Universitario de Gran Canaria Doctor Negrín

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: May 1, 2019
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

ES (1)