CholecystolithiasisPhase 4INTENSENCT01199406
Pain Reduction After Cholecystectomy
A Phase 4 study testing Levobupivacaine in people with Cholecystolithiasis and Postoperative Pain, run by Meander Medical Center at 1 site in Netherlands.
Trial summary
To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystolithiasis, Postoperative Pain
- What is being tested?
- Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Jan 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 80
- ASA I or II
- with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy
Who cannot join
- acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
- a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
- pregnancy
- patients suffering from hypotension or hypovolemia
- infectious liver disease
- conditions obstructing adequate pain scoring
- patients using drugs that deduce function of the CYP3A4 or CYP1A2 system
- patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial
To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.
Read the detailed description
The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.
- Conditions
- Cholecystolithiasis, Postoperative Pain
- Being tested
- Levobupivacaine
- Keywords
- gallstone, gallbladder, cholecystectomy, laparoscopic, pain
- Medical subject headings
- Cholecystolithiasis, Pain, Postoperative, Gallstones, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine (brand name), NDA 20-997
0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | 80 mL 0.9% NaCl Receives: Drug: Levobupivacaine |
| Levobupivacaine | Experimental | 80mL 0.125% levobupivacaine Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
Postoperative abdominal pain
Measured: 24 h postoperatively
Secondary outcomes (6)
Shoulder pain
Postoperative shoulder pain
Measured: 24 h
Rescue Analgesics
The need of rescue analgesics within the 24h postoperatively
Measured: 24 h postoperatively
adverse events caused by the investigational procedure or by levobupivacaine itself
Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered.
Measured: Intra- and postoperative up to 24 hours
Length of hospital stay
Measured: Maximum two weeks
intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures
Measured: intraoperative, 1 hour
postoperative complications during hospitalisation
Infection, bleeding, embolisation etc.
Measured: during hospitalisation (up to two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meander Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Werner A Draaisma, MD, PhD, Study chair, Meander MCBart Hilvering, MD, Principal investigator, Meander MCEsther CJ Consten, MD, PhD, Study director, Meander MCKristine E Kofman, MD, Study chair, Meander MCRene M Valk, MD, Study chair, Meander MCJarmila DW Van der Bilt, MD, Study chair, Meander MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199406
- Sponsor's protocol ID
- Intense Trial
- Acronym
- INTENSE
- Status last verified
- Sep 2010
- First submitted
- 9 Sep 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hilvering B, Draaisma WA, van der Bilt JD, Valk RM, Kofman KE, Consten EC. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. Br J Surg. 2011 Jun;98(6):784-9. doi: 10.1002/bjs.7435. Epub 2011 Mar 17.
PubMed 21412996
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01199406
- Acronym / sponsor ID
- INTENSE / Intense Trial
- Conditions
- Cholecystolithiasis, Postoperative Pain
- Keywords
- gallstone, gallbladder, cholecystectomy, laparoscopic, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Meander Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Sep 2010 (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 determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.
Detailed description
The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Drug: Levobupivacaine80 mL 0.9% NaCl |
| Levobupivacaine | Experimental | Drug: Levobupivacaine80mL 0.125% levobupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 80
- ASA I or II
- with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy
Key exclusion criteria (8 listed)
- acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
- a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
- pregnancy
- patients suffering from hypotension or hypovolemia
- infectious liver disease
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 |
|---|---|---|
| LevobupivacaineAlso: Chirocaine (brand name), NDA 20-9970.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally | Drug | Levobupivacaine, normal saline |
Primary outcome
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
Time frame: 24 h postoperatively
Postoperative abdominal pain
6 secondary outcomes
Shoulder pain
Time frame: 24 h
Rescue Analgesics
Time frame: 24 h postoperatively
adverse events caused by the investigational procedure or by levobupivacaine itself
Time frame: Intra- and postoperative up to 24 hours
Length of hospital stay
Time frame: Maximum two weeks
intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures
Time frame: intraoperative, 1 hour
postoperative complications during hospitalisation
Time frame: during hospitalisation (up to two weeks)
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 13 Sep 2010.
- Derived from this study: PubMed 21412996Hilvering B, Draaisma WA, van der Bilt JD, Valk RM, Kofman KE, Consten EC. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. Br J Surg. 2011 Jun;98(6):784-9. doi: 10.1002/bjs.7435. Epub 2011 Mar 17.
Related trials for Cholecystolithiasis
RecruitingObservational study
A Survey of Public Attitudes Towards Gallbladder-preserving Lithotomy and Its Influencing Factors
Cholecystolithiasis
Recruiting
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Cholecystolithiasis, Common Bile Duct Gall Stones
Not yet recruitingPhase 2
A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy
Gallbladder Stones, Gallbladder Polyps
Active, not recruiting
Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy.
Ovarian Cancer, Cholecystolithiasis
Recruiting
Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway
Cholelithiases, Cholecystolithiasis
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.
Werner A Draaisma, MD, PhD study chair
Meander MC
Bart Hilvering, MD principal investigator
Meander MC
Esther CJ Consten, MD, PhD study director
Meander MC
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 Levobupivacaine in people with Cholecystolithiasis and Postoperative Pain, run by Meander Medical Center at 1 site in Netherlands.
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 3 inclusion and 8 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 13 Sep 2010. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) (time frame: 24 h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199406, which also lists 1 linked publication.
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 13 Sep 2010; AzTrials last refreshed its copy on 30 Oct 2026.