Analgesic efficacy of wound infiltration vs ultrasound-guided transversus abdominis plane block in laparoscopic colorectal surgery

Phase 1

Recruiting

• Conditions: Patients scheduled for laparoscopic colorectal surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2023-507090-18-00
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients scheduled for laparoscopic colorectal surgery (right or left hemicolectomy, extended hemicolectomy, high anterior resection, total colectomy or sigmoidectomy)., Age >18 years., Completed informed consent. Patients who agrees to participate in the study by signing the informed consent., ASA 1-3, Willingness to NOL monitor

Exclusion Criteria

Urgent surgery., Obesity grade II or higher (BMI >35kg/m2)., Known allergy to local anesthetics or other drugs included in protocol., Psychiatric disturbances that prevent clinical assessment of pain., Absence of NOL monitor., Previous history of chronic pain with habitual opioid use., If the surgery is converted to open surgery, the patient will be excluded from the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare total perioperative opioid consumption in each of the study groups at 48h expressed as morphine milligram equivalent.;Secondary Objective: To compare total perioperative opioid consumption in each of the study groups at post-anesthesia recovery unit (PACU) and 24h after surgery., To compare postoperative pain score at rest and movement by visual analog scale (VAS) or numeric rate score (NRS) at post-anesthesia recovery unit, 24h and 48h after surgery., To determine if there is any difference in the incidence of nausea and vomiting at post-anesthesia recovery unit, 24h and 48h after surgery., To determine if there are differences in the onset of oral tolerance, ambulation movilization and length of hospital stay.;Primary end point(s): Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU) and 24h after surgery.;Secondary end point(s):Difference between pain score at rest and movement (by VAS or NRS) of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.;Secondary end point(s):Difference between the incidence of nausea and vomiting of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.;Secondary end point(s):Difference between the onset of oral tolerance, ambulation movilization and length of hospital stay of TAP group versus Wound Infiltration (WI) group.