CholecystolithiasisPhase 4NCT00209885
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
A Phase 4 study testing Gabapentin, S-ketamine and Lidocaine in people with Cholecystolithiasis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- Gabapentin, S-ketamine and Lidocaine
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to not given
- 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
- Age above 18 years
- Written informed consent
- ASA class I-III
Who cannot join
- Planned abdominal cholecystectomy
- Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
- Allergy to part of the treatment regimens
- Previous reactions to opioids (nausea, cognition)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Anaesthesia, Hvidovre Hospital
Copenhagen, Hvidovre, 2650
Kenneth Jensen, M.D., +45 36 32 62 90, kenneth.jensen@hh.hosp.dk
Kenneth Jensen, M.D.
About this study
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU
Read the detailed description
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:
- A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.
Primary endpoints:
- postoperative abilities over time
- discharge time from PACU according to fixed criteria
- consumption of analgesics and antiemetics in the PACU
Secondary endpoints:
- degree of nursing requirements at the PACU
- General tolerability of the regimes
- Conditions
- Cholecystolithiasis
- Being tested
- Gabapentin, S-ketamine, Lidocaine, Droperidol
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
S-ketamineDrug
LidocaineDrug
DroperidolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. postoperative abilities over time in PACU
2. discharge time from PACU according to fixed criteria
3. consumption of analgesics and antiemetics in the PACU
Secondary outcomes (2)
1. Degree of nursing requirements in the PACU
2. General tolerability of the regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Jensen, M.D., Principal investigator, Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, DenmarkClaus Lund, dr.med.sci, Study chair, Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209885
- Sponsor's protocol ID
- OMA-LC01
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00209885
- Acronym / sponsor ID
- OMA-LC01
- Conditions
- Cholecystolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 21 Sep 2005 (estimated)
- 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.
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU
Detailed description
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:
- A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.
Primary endpoints:
- postoperative abilities over time
- discharge time from PACU according to fixed criteria
- consumption of analgesics and antiemetics in the PACU
Secondary endpoints:
- degree of nursing requirements at the PACU
- General tolerability of the regimes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective laparoscopic cholecystectomy
- Age above 18 years
- Written informed consent
- ASA class I-III
Key exclusion criteria (4 listed)
- Planned abdominal cholecystectomy
- Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
- Allergy to part of the treatment regimens
- Previous reactions to opioids (nausea, cognition)
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 |
|---|---|---|
| Gabapentin | Drug | – |
| S-ketamine | Drug | – |
| Lidocaine | Drug | – |
| Droperidol | Drug | – |
Primary outcome
1. postoperative abilities over time in PACU
2. discharge time from PACU according to fixed criteria
3. consumption of analgesics and antiemetics in the PACU
2 secondary outcomes
1. Degree of nursing requirements in the PACU
2. General tolerability of the regimens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- URL looking into anaesthesia and surgery for cholecystectomyLink provided by the sponsor.
Related trials for Cholecystolithiasis
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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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.
Kenneth Jensen, M.D. principal investigator
Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Claus Lund, dr.med.sci study chair
Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
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 Gabapentin, S-ketamine and Lidocaine in people with Cholecystolithiasis, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2005. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Jensen, M.D. (+45 36 32 62 90, kenneth.jensen@hh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. postoperative abilities over time in PACU. The study lists 3 primary outcomes in all. 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 21 Sep 2005.