Clinical trial NCT05222789: Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
Official title: Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain, Acute
Postoperative Pain, Chronic
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10
timeFrame: from the arrival to the postanesthesia care unit to the 4 postoperative hours
measure: Intraoperative analgesic consumption
timeFrame: from the anesthesia induction to the end of the surgery
Secondary outcomes:
measure: Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10
timeFrame: 2 years postoperatively
measure: Side effects
timeFrame: from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively)
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Becerra
role: PRINCIPAL_INVESTIGATOR
References: