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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
TAP Block and Dexamethasone
TAP Block and saline
TAP Block and Dexamethasone i.v.
Sponsored by
San Salvatore Hospital of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Analgesia, Dexamethasone, Levobupivacaine, Ultrasound-guided, Tranversus Abdominis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emiliano Petrucci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

TAP Block and Dexamethasone

TAP Block and Saline

TAP Block and Dexamethasone i.v.

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
May 11, 2016
Last Updated
April 17, 2019
Sponsor
San Salvatore Hospital of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT02783144
Brief Title
Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia
Official Title
Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Salvatore Hospital of L'Aquila

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Analgesia, Dexamethasone, Levobupivacaine, Ultrasound-guided, Tranversus Abdominis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block and Dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
TAP Block and Saline
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
TAP Block and Dexamethasone i.v.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TAP Block and Dexamethasone
Other Intervention Name(s)
TAP-Block under ultrasound guidance and dexamethasone
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
TAP Block and saline
Other Intervention Name(s)
TAP-Block under ultrasound guidance and saline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TAP Block and Dexamethasone i.v.
Other Intervention Name(s)
TAP-Block under ultrasound guidance and i.v. dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
Extension of analgesia, assessed in minutes after TAP block
Description
After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Rest pain, assessed with Visual Analog Scale
Description
Rest pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).
Time Frame
24 hours after surgery
Title
Incident pain, assessed with Visual Analog Scale
Description
Incident pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano Petrucci
Organizational Affiliation
San Salvatore Academic Hospital of L'Aquila
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emiliano Petrucci
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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