NCT04697329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

December 23, 2020

Last Update Submit

May 26, 2022

Conditions

Laparoscopic CholecystectomyPostoperative PainLocal InfiltrationLevobupivacaine

Keywords

Laparoscopic cholecystectomyPostoperative PainLocal InfiltrationLevobupivacaineRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative administration of analgesics

    24 hours

  • Postoperative nausea and vomiting episodes

    24 hours

Study Arms (2)

Local infiltration

EXPERIMENTAL
Drug: Preincisional infiltration with levobupivacaine

No local infiltration

NO INTERVENTION

Interventions

Preincisional infiltration with levobupivacaineDRUG

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

Local infiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopic cholecystectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Móstoles

Móstoles, Madrid, 28935, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • MANUEL DURÁN POVEDA, MD

    H. U. REY JUAN CARLOS

    STUDY DIRECTOR

  • GIL RODRÍGUEZ CARAVACA, MD

    H. F. ALCORCÓN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Surgeon.

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 6, 2021

Study Start

December 3, 2020

Primary Completion

May 26, 2022

Study Completion

May 26, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
March 2022. 6 months.

Locations

ES(1)