Laparoscopic CholecystectomyPhase 4NCT04697329
Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy
A Phase 4 study testing Preincisional infiltration with levobupivacaine in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Hospital Universitario de Móstoles at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain, Local Infiltration
- What is being tested?
- Preincisional infiltration with levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2020to 26 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective laparoscopic cholecystectomy
Who cannot join
- Patient refusal
- Open surgery
- Reintervention surgery
- Drain tube placement
- Cognitive impairment
- Allergic reactions to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
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.
- Being tested
- Preincisional infiltration with levobupivacaine
- Keywords
- Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preincisional infiltration with levobupivacaineDrug
Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration | Experimental | Not described Receives: Drug: Preincisional infiltration with levobupivacaine |
| No local infiltration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (2)
Postoperative administration of analgesics
Record of dose of analgesics needed: nonsteroidal anti-inflamatory drugs, opioid requirements, other analgesics requirements
Measured: 24 hours
Postoperative nausea and vomiting episodes
Record of episodes of nausea or vomiting during first 24 postoperative hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Dec 2020
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Móstoles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE HERRADOR BENITO, Hospital Universitario de Móstoles
- Investigators
- MANUEL DURÁN POVEDA, MD, Study director, H. U. REY JUAN CARLOSGIL RODRÍGUEZ CARAVACA, MD, Study director, H. F. ALCORCÓN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697329
- Sponsor's protocol ID
- HUMOSDEC2020
- Status last verified
- May 2022
- First submitted
- 23 Dec 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04697329
- Acronym / sponsor ID
- HUMOSDEC2020
- Keywords
- Laparoscopic cholecystectomy, Postoperative Pain, Local Infiltration, Levobupivacaine, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Hospital Universitario de MóstolesUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration | Experimental | Drug: Preincisional infiltration with levobupivacaine |
| No local infiltration | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Patient refusal
- Open surgery
- Reintervention surgery
- Drain tube placement
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preincisional infiltration with levobupivacaineLocal, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml | Drug | Local infiltration |
Primary outcome
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
2 secondary outcomes
Postoperative administration of analgesics
Time frame: 24 hours
Postoperative nausea and vomiting episodes
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANUEL DURÁN POVEDA, MD study director
H. U. REY JUAN CARLOS
GIL RODRÍGUEZ CARAVACA, MD study director
H. F. ALCORCÓN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preincisional infiltration with levobupivacaine in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Hospital Universitario de Móstoles at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessed by visual numeric scale. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.