Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia

Study Overview
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Brief Summary
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Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.

Detailed Description
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In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.

Official Title
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Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: TAP Block and Dexamethasone
* Other: TAP Block and saline
* Drug: TAP Block and Dexamethasone i.v.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ASA score I and II age 18 years Exclusion Criteria: Allergy to local anesthetics Allergy to general anesthetics Allergy or intolerance to acetaminophen Severe renal impairment Severe hepatic impairment Congestive heart failure Coagulation disorders hypoprotidemia Diabetes mellitus History Age greater than 70 years Age below 18 years ASA Physical than 3 Status Lack of informed consent Patients unable to discernment Intolerance to opiates Peptic Ulcer Abuse of alcohol and / or drugs

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block and Dexamethasone<br>After general anesthesia and before the beginning of surgery, 4 mg of Dexamethasone are added to 20 ml of 0,375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. | Procedure: TAP Block and Dexamethasone<br>* After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine<br>* Other names: TAP-Block under ultrasound guidance and dexamethasone;|
| Placebo Comparator: TAP Block and Saline<br>After general anesthesia and before the beginning of surgery, 2 ml of saline are added to 20 ml of 0.375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. | Other: TAP Block and saline<br>* After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine<br>* Other names: TAP-Block under ultrasound guidance and saline;|
| Active Comparator: TAP Block and Dexamethasone i.v.<br>After general anesthesia and before the beginning of surgery, 20 ml of 0,375% Levobupivacaine are used in Ultrasound-guided Tranversus Abdominis Plain Block. In this group 4 mg of dexamethasone are injected intravenously. | Drug: TAP Block and Dexamethasone i.v.<br>* After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously<br>* Other names: TAP-Block under ultrasound guidance and i.v. dexamethasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension of analgesia, assessed in minutes after TAP block | After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rest pain, assessed with Visual Analog Scale | Rest pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain). | 24 hours after surgery | 
| Incident pain, assessed with Visual Analog Scale | Incident pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain). | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Dexamethasone, Levobupivacaine, Ultrasound-guided, Tranversus Abdominis