Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

Hospital Universitario de Móstoles

Status and phase: Completed; Phase 4

Conditions: Local Infiltration; Postoperative Pain; Levobupivacaine; Laparoscopic Cholecystectomy

Treatments: Drug: Preincisional infiltration with levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04697329

HUMOSDEC2020

Details and patient eligibility

About

Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.

Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective laparoscopic cholecystectomy

Exclusion criteria

• Patient refusal
• Open surgery
• Reintervention surgery
• Drain tube placement
• Cognitive impairment
• Allergic reactions to local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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233 participants in 2 patient groups

Local infiltration

Experimental group

Treatment:

Drug: Preincisional infiltration with levobupivacaine

No local infiltration

No Intervention group