NCT04697329
Completed
Phase 4
Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
Hospital Universitario de Móstoles1 site in 1 country233 target enrollmentDecember 3, 2020
InterventionsPreincisional infiltration with levobupivacaine
Overview
- Phase
- Phase 4
- Intervention
- Preincisional infiltration with levobupivacaine
- Conditions
- Laparoscopic Cholecystectomy
- Sponsor
- Hospital Universitario de Móstoles
- Enrollment
- 233
- Locations
- 1
- Primary Endpoint
- Postoperative pain assessed by visual numeric scale.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
JORGE HERRADOR BENITO
Principal Investigator. Surgeon.
Hospital Universitario de Móstoles
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
Arms & Interventions
Local infiltration
Intervention: Preincisional infiltration with levobupivacaine
Outcomes
Primary Outcomes
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
- Postoperative administration of analgesics(24 hours)
- Postoperative nausea and vomiting episodes(24 hours)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic CholecystectomyGallbladder StoneGallbladder PolypNCT02185586China-Japan Friendship Hospital105
Completed
Not Applicable
For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View EndoscopeCholedocholithiasis with CholecystitisNCT06599437Damanhour Medical National Institute50
Recruiting
Phase 4
Use of Indocyanine Green in Acute CholecystitisAcute CholecystitisBile Duct InjuryNCT05709548Corporacion Parc Tauli440
Unknown
Phase 2
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder DyskinesiaGallbladder DyskinesiaNCT02195115CAMC Health System60
Completed
Not Applicable
Randomized Control Trial of Intraperitoneal Bupivacaine During CholecystectomyCholecystitisGall Stone PancreatitisNCT01528722University Hospitals Coventry and Warwickshire NHS Trust42