Pain Reduction After Cholecystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial

Conditions
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Cholecystolithiasis, Postoperative Pain

Intervention / Treatment
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* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 80 ASA I or II with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline<br>80 mL 0.9% NaCl | Drug: Levobupivacaine<br>* 0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally<br>* Other names: NDA 20-997;|
| Experimental: Levobupivacaine<br>80mL 0.125% levobupivacaine | Drug: Levobupivacaine<br>* 0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally<br>* Other names: NDA 20-997;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) | Postoperative abdominal pain | 24 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallstone, gallbladder, cholecystectomy, laparoscopic, pain