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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal saline | Placebo Comparator | 80 mL 0.9% NaCl |
|
| Levobupivacaine | Experimental | 80mL 0.125% levobupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | 0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) | Postoperative abdominal pain | 24 h postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain | Postoperative shoulder pain | 24 h |
| Rescue Analgesics | The need of rescue analgesics within the 24h postoperatively | 24 h postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner A Draaisma, MD, PhD | Meander MC | Study Chair |
| Bart Hilvering, MD | Meander MC | Principal Investigator |
| Esther CJ Consten, MD, PhD | Meander MC | Study Director |
| Kristine E Kofman, MD | Meander MC | Study Chair |
| Rene M Valk, MD | Meander MC | Study Chair |
| Jarmila DW Van der Bilt, MD | Meander MC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander MC | Amersfoort | Amersfoort | 3811ES | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21412996 | Derived | 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. |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| D010149 | Pain, Postoperative |
| D042882 | Gallstones |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| 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. | Intra- and postoperative up to 24 hours |
| Length of hospital stay | Maximum two weeks |
| intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures | intraoperative, 1 hour |
| postoperative complications during hospitalisation | Infection, bleeding, embolisation etc. | during hospitalisation (up to two weeks) |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| Aniline Compounds |
| D000588 | Amines |