Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy
Primary Purpose
Laparoscopic Cholecystectomy, Postoperative Pain, Local Infiltration
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Preincisional infiltration with levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Laparoscopic Cholecystectomy focused on measuring Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Elective laparoscopic cholecystectomy
Exclusion Criteria:
- Patient refusal
- Open surgery
- Reintervention surgery
- Drain tube placement
- Cognitive impairment
- Allergic reactions to local anesthetics
Sites / Locations
- Hospital Universitario de Móstoles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Local infiltration
No local infiltration
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postoperative administration of analgesics
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Postoperative nausea and vomiting episodes
Record of episodes of nausea or vomiting during first 24 postoperative hours
Full Information
NCT ID
NCT04697329
First Posted
December 23, 2020
Last Updated
May 26, 2022
Sponsor
Hospital Universitario de Móstoles
1. Study Identification
Unique Protocol Identification Number
NCT04697329
Brief Title
Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy
Official Title
Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Móstoles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine
Keywords
Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local infiltration
Arm Type
Experimental
Arm Title
No local infiltration
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Preincisional infiltration with levobupivacaine
Intervention Description
Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml
Primary Outcome Measure Information:
Title
Postoperative pain assessed by visual numeric scale.
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative administration of analgesics
Description
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Time Frame
24 hours
Title
Postoperative nausea and vomiting episodes
Description
Record of episodes of nausea or vomiting during first 24 postoperative hours
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective laparoscopic cholecystectomy
Exclusion Criteria:
Patient refusal
Open surgery
Reintervention surgery
Drain tube placement
Cognitive impairment
Allergic reactions to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MANUEL DURÁN POVEDA, MD
Organizational Affiliation
H. U. REY JUAN CARLOS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
GIL RODRÍGUEZ CARAVACA, MD
Organizational Affiliation
H. F. ALCORCÓN
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Móstoles
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
March 2022. 6 months.
Learn more about this trial
Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy
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