Analgesia in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

Detailed Description
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Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU). Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes. Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead. VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery. The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.

Official Title
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Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial

Conditions
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Pain, Postoperative, Chronic Postoperative Pain

Intervention / Treatment
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* Drug: Ropivacaine 0.75
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III Scheduled for laparoscopic cholecystectomy Exclusion Criteria: Patients with chronic pain and/or on analgesics for the last month, Patients with central nervous, kidney and liver disease, or allergy to local anesthetics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine 0.75<br>Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours | Drug: Ropivacaine 0.75<br> <br> * Other names: Naropeine;|
| Placebo Comparator: Normal saline<br>Continuous infusion of normal saline 2 ml/h for 24 hours | Drug: Normal saline<br> <br> * Other names: 0.9% saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Score Changes ( Cough) During 24 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores in the Postoperative Care Unit (PACU) at Rest | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | in PACU | 
| Pain Scores at Rest 2 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 2 h postoperatively | 
| Pain Scores at Rest 4 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 4 h | 
| Pain Scores at Rest 8 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 8 h | 
| Pain Scores at Rest 24 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 24h | 
| Pain Scores at Rest 48 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 48 h | 
| Pain Scores During Cough in the PACU | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | PACU | 
| Pain Scores During Cough 2 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 2 h | 
| Pain Scores During Cough 4 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 4 h | 
| Pain Scores During Cough 8 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 8 h | 
| Pain Scores During Cough 48 h Postoperatively | Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain. | 48 h | 
| Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively | one month postoperatively | 
| Chronic Pain | Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic