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

Phase 4

Recruiting

• Conditions: Patients scheduled for laparoscopic colorectal surgery

• Registration Number: 2023-507090-18-00
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

To compare total perioperative opioid consumption in each of the study groups at 48h expressed as morphine milligram equivalent.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• 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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.		Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.

Secondary Outcome Measures

Name	Time	Method
Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU) and 24h after surgery.		Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU) and 24h after surgery.
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.		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.
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.		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.
Difference between the onset of oral tolerance, ambulation movilization and length of hospital stay of TAP group versus Wound Infiltration (WI) group.		Difference between the onset of oral tolerance, ambulation movilization and length of hospital stay of TAP group versus Wound Infiltration (WI) group.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz

🇪🇸Madrid, Spain

María Cristina Rodríguez Roca

Site contact

917277000

rocamc04@gmail.com