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

April 17, 2019 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • L'Aquila, Italy, 67100
        • Emiliano Petrucci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP Block and Dexamethasone
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
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
Other Names:
  • TAP-Block under ultrasound guidance and dexamethasone
Placebo Comparator: TAP Block and Saline
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
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
Other Names:
  • TAP-Block under ultrasound guidance and saline
Active Comparator: TAP Block and Dexamethasone i.v.
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.
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
Other Names:
  • TAP-Block under ultrasound guidance and i.v. dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extension of analgesia, assessed in minutes after TAP block
Time Frame: 24 hours after surgery
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
Time Frame: 24 hours after surgery
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
Time Frame: 24 hours after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Salvatore Hospital of L'Aquila

Investigators

  • Principal Investigator: Emiliano Petrucci, San Salvatore Academic Hospital of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2017

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

April 15, 2019

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0024575/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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