NCT02783144

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
Completed

Started Jun 2017

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

May 11, 2016

Last Update Submit

April 17, 2019

Conditions

Postoperative Pain

Keywords

AnalgesiaDexamethasoneLevobupivacaineUltrasound-guidedTranversus Abdominis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rest pain, assessed with Visual Analog Scale

    24 hours after surgery

  • Incident pain, assessed with Visual Analog Scale

    24 hours after surgery

Study Arms (3)

TAP Block and Dexamethasone

EXPERIMENTAL

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

TAP Block and Saline

PLACEBO COMPARATOR

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

TAP Block and Dexamethasone i.v.

ACTIVE COMPARATOR

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.

Interventions

TAP Block and DexamethasonePROCEDURE

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

Also known as: TAP-Block under ultrasound guidance and dexamethasone
TAP Block and Dexamethasone
TAP Block and salineOTHER

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

Also known as: TAP-Block under ultrasound guidance and saline
TAP Block and Saline
TAP Block and Dexamethasone i.v.DRUG

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

Also known as: TAP-Block under ultrasound guidance and i.v. dexamethasone
TAP Block and Dexamethasone i.v.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA score I and II
  • age 18 years

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emiliano Petrucci

L’Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Emiliano Petrucci

    San Salvatore Academic Hospital of L'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 26, 2016

Study Start

June 28, 2017

Primary Completion

March 13, 2019

Study Completion

April 15, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)