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Completed

NCT Number: NCT04697329

Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Levobupivacaine Local Infiltration Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Móstoles

Móstoles, Madrid, 28935, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective laparoscopic cholecystectomy

Exclusion criteria

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

Treatment and study plan

Preincisional infiltration with levobupivacaine

Drug

Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml

Primary outcomes

  1. Postoperative pain assessed by visual numeric scale.

    Time frame: 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 outcomes

  1. Postoperative administration of analgesics

    Time frame: 24 hours

    Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements

  2. Postoperative nausea and vomiting episodes

    Time frame: 24 hours

    Record of episodes of nausea or vomiting during first 24 postoperative hours

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Móstoles

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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