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NCT04697329 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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