Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

Phase 4

Completed

• Conditions: Postoperative Pain; Levobupivacaine; Laparoscopic Cholecystectomy; Local Infiltration
• Interventions: Drug: Preincisional infiltration with levobupivacaine

• Registration Number: NCT04697329
• Lead Sponsor: Hospital Universitario de Móstoles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Status Verified: 2022-05
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Elective laparoscopic cholecystectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration	Preincisional infiltration with levobupivacaine	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessed by visual numeric scale.	24 hours	Values come from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Best outcome would be 0 or close to 0

Secondary Outcome Measures

Name	Time	Method
Postoperative administration of analgesics	24 hours	Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Postoperative nausea and vomiting episodes	24 hours	Record of episodes of nausea or vomiting during first 24 postoperative hours

Trial Locations

Locations (1)

Hospital Universitario de Móstoles; 🇪🇸 Móstoles, Madrid, Spain