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Clinical Trials/2024-514790-22-00
2024-514790-22-00
Not yet recruiting
Phase 4

Transversus Abdominis Plane (TAP) Block vs. Laparoscopic Port Site Wound Infiltration in Patients with Colorectal Cancer Undergoing Scheduled Laparoscopic Surgery Included in the Enhanced Recovery After Surgery (ERAS) Program

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana1 site in 1 country174 target enrollmentStarted: September 3, 2024Last updated:
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Overview

Phase
Phase 4
Status
Not yet recruiting
Enrollment
174
Locations
1
Primary Endpoint
Pain intensity measured with the visual analog scale (VAS),
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To compare postoperative pain between two analgesic techniques: transversus abdominis plane block and infiltration of laparoscopy port wounds with local anesthetic.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients > 18 years old.
  • •Scheduled for laparoscopic colorectal cancer surgery (right hemicolectomy, left hemicolectomy, total colectomy, abdominoperineal resection of the rectum, low or ultra-low anterior resection of the rectum).

Exclusion Criteria

  • •Urgent colorectal cancer surgery.
  • •Allergy to local anesthetics.
  • •Patient refusal to undergo analgesic techniques.
  • •Patient refusal to participate in the study.
  • •BMI > 35 or < 50 kg.
  • •Chronic opioid therapy
  • •Communication difficulties due to language barrier or pathology.

Outcomes

Primary Outcomes

Pain intensity measured with the visual analog scale (VAS),

Pain intensity measured with the visual analog scale (VAS),

Secondary Outcomes

  • Consumption of minor and major opioids during admission: The milligrams of minor (tramadol) and major (morphine) opioids administered to the patient will be recorded. Data collection times will be the same as for the VAS, at 2, 6, 24, and 48 hours after surgery completio
  • Incidence of postoperative nausea and vomiting

Investigators

Sponsor Class
Patient organisation/association
Responsible Party
Principal Investigator
Principal Investigator

Juan Vicente Llau Pitarch

Scientific

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Study Sites (1)

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