Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery (TAP)

Postoperative Pain Assessment 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute; Postoperative Pain, Chronic
• Intervention / Treatment: Procedure: TAP

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Ángel Becerra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAP block; Patients receiving TAP block preoperatively, following routine clinical practice	Procedure: TAP; 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.
Non-TAP; Patients not receiving TAP block preoperatively, following routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10	assessed using visual analogue scale	2 years postoperatively
Side effects	to record the perioperative side effects secondary to the analgesia administered perioperatively	from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively)

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital
• Investigators: Principal Investigator: Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: ARP-ANA-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No