TAP: Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery

• Sponsor: Dr. Negrin University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05222789
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain, Acute; Postoperative Pain, Chronic	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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10 [from the arrival to the postanesthesia care unit to the 4 postoperative hours]

   assessed using visual analogue scale

2. Intraoperative analgesic consumption [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 Outcome Measures

1. Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10 [2 years postoperatively]

   assessed using visual analogue scale

2. Side effects [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas	Spain	35019

Sponsors and Collaborators

• Dr. Negrin University Hospital

Investigators

• Principal Investigator: Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
• ClinicalTrials.gov Identifier: NCT05222789
• Other Study ID Numbers: ARP-ANA-2015-01
• First Posted: Feb 3, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Acute Pain; Chronic Pain

Study Results

No Results Posted as of May 2, 2022