Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697329
• Other study ID #: HUMOSDEC2020
• Status: Completed
• Phase: Phase 4
• Start date: December 3, 2020
• Est. completion date: May 26, 2022

Study information

• Verified date: May 2022
• Source: Hospital Universitario de Móstoles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective laparoscopic cholecystectomy

Exclusion Criteria:

• Patient refusal

• Open surgery

• Reintervention surgery

• Drain tube placement

• Cognitive impairment

• Allergic reactions to local anesthetics

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Levobupivacaine
• Local Infiltration
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Preincisional infiltration with levobupivacaine
Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml

Locations

Country	Name	City	State
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Móstoles

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain assessed by visual numeric scale.	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	24 hours
Secondary	Postoperative administration of analgesics	Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements	24 hours
Secondary	Postoperative nausea and vomiting episodes	Record of episodes of nausea or vomiting during first 24 postoperative hours	24 hours